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CONFERENCE
MAY
28
8:30 AM
The A to Z's of Microbial Control, Monitoring and Validation of Water Systems for Pharmaceuticals
, Newark, NJ, USA
Course Description: All facilities manufacturing pharmaceuticals, biologics, medical devices, cosmetics, and personal care products are likely to have high purity water systems. In spite of this purity, microorganisms can flourish within these systems and lead to undesirable contamination of facility processes and their products. Of all the individuals at the facility, it is site’s microbiologists who should understand the microorganisms in water systems and how best to monitor and control them. Sadly, this is often not the case due to the lack of familiarity with biofilm and its impact on...
CONFERENCE
MAY
28
8:30 AM
Elements of Current Good Manufacturing Practices
to be announced shortly, Minneapolis, MN, USA
Course Description: In this two day workshop conference you will learn the various rules regulating the development, manufacturing and quality assurance of products manufactured for animals and humans, the basis of Hazard analysis and critical control points (HACCP) and the preventative measures soon to be enacted for mitigating the exposure of adulterated products to the end user. Steps can be implemented immediately from this course such as ensuring that the personnel have been properly instructed and the training documented on critical control points established for preventing adulterated...
CONFERENCE
MAY
28
8:30 AM
The A to Z of Trade Compliance for a U.S. Entity
to be announced shortly, San Diego, CA, USA
Course Description: Trade Compliance plays a prominent role in international business today. This course will provide you with the tools, knowledge, and mindset needed to make an immediate impact within the organization you currently represent in the U.S. You will learn the basic requirements of import and export transactions to and from the U.S. There is a cost to non-compliance and you will learn how to communicate those costs to decision makers that control the direction and budget size of a company's trade compliance program. Is your company demonstrating "reasonable care" which is the...
CONFERENCE
MAY
28
8:30 AM
Understanding the Statistical Considerations for Quantitative ICH Guidelines
venue to be announced shortly, New Orleans, LA, USA
Course Description: This course is designed to introduce to individuals the understanding and interpretation of the statistical concepts with reference to certain quantitative ICH Guidelines that apply across laboratory (drug development) and clinical development (drug/device) procedures such as analytical methods in validation and acceptance criteria in calibration procedures, risk management and process monitoring as well as dealing with uncertainties and other relevant issues. It is not a course in statistics but introduces the participant to a hands on approach to the statistical...
SEMINAR
JUN
01
8:30 AM
Risk Based Internal Auditing (RBIA): 2-day Comprehensive Training Workshop
Residence Inn New York Manhattan/Central Park, 1717 Broadway, New York, NY 10019, USA
Course Description: Risk Based Internal Auditing (RBIA) is defined by the Institute of Internal Auditors (IIA) as “a methodology that links internal auditing to an organization’s overall risk management framework”. RBIA allows internal audit to provide assurance to the bank’s/ organization’s board that various risk management processes are managing risks effectively, in relation to the risk appetite of the bank/ organization. However every organization is different with different attitudes to risk, different management and organizational structures, different processes and...
SEMINAR
JUN
02
8:30 AM
Quality Control Laboratory Compliance - cGMPs and GLPs: One and a Half-day In-person Seminar
Embassy Suites Chicago - Downtown/Lakefront, 511 N Columbus Dr, Chicago, IL 60611, USA
Course Description: FDA inspection and oversight of quality control (QC) laboratories are essential elements of the agency’s evaluation of the compliance status of regulated companies representing multiple industries - pharmaceuticals, biologics, medical devices, as well as foods and cosmetics - as well as the contract QC laboratories which service these industries. Lack of compliance can result in severe regulatory actions, criminal liability, fines, and the inability to obtain product approvals. This course will examine the fundamental requirements for all QC laboratories subject to FDA...
SEMINAR
JUN
04
8:30 AM
Operations Risk Management and Mitigation - from Assessment to Implementation
Residence Inn New York Manhattan/Central Park, 1717 Broadway, New York, NY 10019, USA
Aims Recently, a series of headline-grabbing operational risk incidents at banks, other financial institutions and even regulators have again brought the issue of operational risk management to the forefront of the agendas of CEOs, CROs, risk managers and internal and external auditors alike. These incidents are wide ranging and flow from bank ATM collapses, bank operating system failures, regulatory settlements in the ongoing US sub-prime mortgage saga, rogue traders and the connected risk managers who either missed or were willfully blind to all the warning signs. As the size and...
SEMINAR
JUN
04
8:30 AM
Human Resources and Employment Law Essentials: 2-Day In-Person Seminar
Houston Marriott West Loop by the Galleria, 1750 W Loop S Fwy, Houston, TX 77027, USA
Course Description: Is your company at risk for non-compliance? Is your company a lawsuit waiting to happen? Employment lawsuits are on the rise. Last year, Equal Employment Opportunity Commission (EEOC) enforcement collected $372.1 million in monetary damages, the highest recovery in agency history. Also, for the last three years, the EEOC reported a record high number of claims filed by employees. When employers are not properly prepared for workplace issues, companies could face discrimination suits, litigation, settlements, lawyer fees, unplanned expenses, employee turnover, morale...
SEMINAR
JUN
04
8:30 AM
Managing an Effective AML Compliance Program: 2-day In-Person Seminar
Renaissance Los Angeles Airport Hotel, 9620 Airport Blvd, Los Angeles, CA 90045, USA
Course Description: Are the financial transactions within your organization subject to money laundering risk? Do you have a robust internal controls program that focuses on mitigating the greatest AML/Fraud risks? Are your employees aware of the red flags within all financial transaction business processes and know what to do if they find unusual or suspicious activity? Are your company and management are up to date on its compliance requirements and the potential impact of non-compliance? Whether you need to get back-to-basics or you are a seasoned AML professional, join us as we explore...
CONFERENCE
JUN
04
8:30 AM
Essentials of ERM and Assessing its Effectiveness Using ISO 31000
Embassy Suites Chicago - Downtown/Lakefront, 511 N Columbus Dr, Chicago, IL 60611, USA
Course Description: If an internal audit is to assess the effectiveness of the organization's risk management program, every member of the audit team has to understand the underlying principles. This two-day course on ERM will introduce internal auditors to the principles and practices of risk management. It is a course for all types of organizations, whether public or private, and in all sectors and industries. This course will focus on the ISO 31000:2009 global risk management standard. It will also cover some of the principles behind the alternative COSO Enterprise Risk Management -...
SEMINAR
JUN
08
8:30 AM
Essentials Of USP Microbiology - Reading Between the Lines of the USP General
Grand Hyatt San Francisco, 345 Stockton St, San Francisco, CA 94108, USA
Course Description: The objective of this two day "Essentials of USP Microbiology" seminar is to explore USP General and General Information Chapters to learn which are available and to confirm that those that you are using are being used correctly. USP documents that will be reviewed include USP , , , , , , , , and others. Various team exercises will be conducted to allow the participants to use these USP documents to solve "real life" problems. Plan to bring a cross-functional group of your personnel to attend this invaluable two day seminar. Learning Objectives: The various General...
CONFERENCE
JUN
08
8:30 AM
Global Food Supply Chain Risk and Blue Ocean Strategy Using Supply Chain Management
, London, UK
Global Food Supply Chain Risk Day 1 - Monday, June 8, 2015, 8:30 AM to 4:30 PM BST Course Description: Global food supply chain risk is about more than data analytics! The food supply chain begins in fields and runs through processors and into warehouses in the destination countries. It includes all types of foods--agriculture, meats, and sea foods in all ways—fresh, live, chilled, frozen, and more. Our seminar is unique in that we know supply chain management and can discuss what food supply chain risk is and how to...
SEMINAR
JUN
09
8:30 AM
FDA's Medical Device Software Regulation Strategy: 2-Day In-Person Seminar by Ex-FDA Official
JW Marriott Houston, 5150 Westheimer Rd, Houston, TX 77056, USA
Course Description: The growth of the medical software industry outpaces the design of FDA's regulatory process. In some instances clinicians have weighed the risk of software failure against the benefits of using a device at all. Device software is often used in conjunction with other software-based devices, but their interoperability was never anticipated. How can you anticipate and defend against the malicious remote hacking and shut down of an insulin infusion pump? Can one software program defeat the performance capability or back up safety features of another software program? ...
SEMINAR
JUN
11
8:30 AM
Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions
Grand Hyatt San Francisco, 345 Stockton St, San Francisco, CA 94108, USA
Course Description: Raw material requirements in a cGMP environment are often overlooked as a company develops new products. Depending on the product being developed, e.g., tablets and capsules vs. biotechnology products, as few as fifteen to twenty or as many as sixty raw materials need to be sourced before the process can be moved from initiation through completion. This highly interactive two day seminar on raw material requirements in a cGMP environment will: Consider Health Canada, FDA, USP and EP requirements. Examine a variety of the issues surrounding raw materials to include...
SEMINAR
JUN
11
8:30 AM
Post-Market Compliance for Medical Devices and Evolving Reporting Requirements
Embassy Suites Chicago - Downtown/Lakefront, 511 N Columbus Dr, Chicago, IL 60611, USA
Course Description: This interactive one and a half day course led by Ms. Rita Hoffman, Former FDA CDRH Recall Branch Chief, who has more than 36 years’ experience with the FDA will provide the participants tools to minimize risk of regulatory enforcement actions. During the seminar, Ms. Hoffman will explain proper handling of complaints reportable or non-reportable, product complaint handling and documentation, how and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall. She will also discuss...
SEMINAR
JUN
11
8:30 AM
Auditing the Human Resource Function & Human Resource Metrics: 2-day In-person Seminar
, Philadelphia, PA, USA
Course Description: This seminar will cover auditing human resources practices for compliance and liability to help identify and correct any areas that may not comply with applicable laws and/or do not comply with company policies. This action not only is a means to perform "due diligence" for your company, but is a measuring tool to determine what needs to be improved to achieve a higher standard of excellence. Areas Covered in the seminar: An overview of labor laws that apply to your business Legal postings. Record setup, access and maintenance. Auditing your employee policy manual. ...
SEMINAR
JUN
11
8:30 AM
FDA's New Import Program Concerning International Consequences: 2-day In-person Seminar
Houston Marriott West Loop by the Galleria, 1750 W Loop S Fwy, Houston, TX 77027, USA
Course Description: Importing products regulated by the FDA has become more complicated. The FDA is using increasingly strict criteria. In order to ensure that your imported product does not get detained or refused entry, you should be knowledgeable about FDA requirements for foods, medicines, medical devices, cosmetics and radiation emitting devices. In addition, there are import requirements that are enforced by U.S. Customs and Border Protection (CBP) and intersect with the FDA’s legal requirements. When products are detained, the situation becomes a very costly problem, and a firm...
CONFERENCE
JUN
11
8:30 AM
Internal Control Best Practices for your Procure to Pay (P2P) Process
Grand Hyatt San Francisco, 345 Stockton St, San Francisco, CA 94108, USA
Course Description: This two day seminar will focus on internal controls best practices for the Procure to Pay (P2P) process. Attendees will learn about internal controls best practices by reviewing the Internal Controls Questionnaires (ICQ) for each component of the P2P process. The course material will highlight the impact that the P2P process can have on an organization and will also indicate the key risks that must be considered within a P2P internal controls program. The course will follow an Internal Controls Questionnaire (ICQ) approach to the course material that will review each...
SEMINAR
JUN
18
8:30 AM
Detecting and Preventing Internal and External Fraud: 2-day In-person Seminar
Embassy Suites Chicago - Downtown/Lakefront, 511 N Columbus Dr, Chicago, IL 60611, USA
Course Description: Organizations of all kinds and sizes are increasingly threatened by fraud. Embezzlement, kickbacks, check fraud, financial statement fraud and vendor billing schemes are just a few of the countless economic crimes committed by employees and outsiders. This two day interactive in-person seminar will provide auditors and other financial professionals with a strong foundation of practical knowledge about how common frauds are committed using a combination of lecture, exercise and group breakout sessions. Learning Objective: Understanding the fraud problem Identify the...
SEMINAR
JUN
18
8:30 AM
SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations
Courtyard Boston Cambridge, 777 Memorial Dr, Cambridge, MA 02139, USA
Course Description: Formal written Standard Operating Procedures (SOPs) are required both by the Food and Drug Administration (FDA) and European Medicines Agency (EMA). Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and many times are hard for the personnel who follow them to understand. They are frequently poorly written, communicated, monitored and enforced. This two day In-person...
SEMINAR
JUN
18
8:30 AM
Building a Vendor Qualification Program for FDA Regulated Industries
, Fort Lauderdale, FL, USA
Course Description: If you are looking for the answer to the following questions, you will certainly benefit from attending this seminar on building a vendor qualification program: Have you wasted hours, days, and weeks on qualifying vendors that you know cannot or will not meet your requirements? Has your approach to vendor qualification and vendor audits left you with internal CAPAs, customer audit items, or 483 observations? Have you wondered whether an onsite vendor audit is necessary in the eyes of FDA? Well, the answers to these and many more questions are now available in a...
SEMINAR
JUN
25
8:30 AM
Regulatory Compliance for Dietary Supplements in the US, EU and Canada: 2-day In-person Seminar
, Salt Lake City, UT, USA
Course Description: A growing public demand for supplements has resulted in a flurry of companies creating and marketing dietary supplements in the United States, EU and Canada. With the regulatory authorities beginning to take a stronger stance on enforcement of regulatory policies, procedures and GMP compliance, it is important for companies to verify that their products comply with the latest regulations and provisions if they plan to market Supplements in these countries. This 2-day interactive live seminar will review the regulations that impact Dietary Supplements in the US, EU and...
SEMINAR
JUN
25
8:30 AM
Computer System Validation - Reduce Costs and Avoid 483s: 2-day In-person Seminar
Grand Hyatt San Francisco, 345 Stockton St, San Francisco, CA 94108, USA
Course Description: Significant changes in the regulations and industry standards for software validation are detailed in this interactive two-day course. The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation related to FDA 21 CFR Part 11, European Annex 11, and HIPAA electronic security regulations for patient medical records. Today the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated...
SEMINAR
JUN
25
8:30 AM
21 CFR Part 11 Compliance for SaaS/Cloud Applications: 2-day In-person Seminar
Grand Hyatt San Francisco, 345 Stockton St, San Francisco, CA 94108, USA
Course Description: Significant changes in the regulations and industry standards for software validation are detailed in this interactive two-day course. The instructor will address the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation related to FDA 21 CFR Part 11, European Annex 11, and HIPAA electronic security regulations for patient medical records. Today the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11...
CONFERENCE
JUN
25
8:30 AM
Project Management in Human Resources: 2-Day In-Person Seminar
, San Diego, CA, USA
Course Description: Naturally, getting a project to deliver on time, within budget, and in line with quality standards requires savvy management. And, the bigger the project, the more challenging good management becomes. As a professional, you're expected to transform a vague concept into a measurable outcome by channeling a broad array of knowledge, skills, and resources toward a critical organizational goal. This two-day workshop is a practical and comprehensive introduction to the many facets of project management specifically designed for the human resource professional. As a...
CONFERENCE
JUN
25
8:30 AM
The European Clinical Trial Directive…Plus…European Filings and Registration Procedures
, Tampa, FL, USA
Course Description: This interactive two day seminar will cover the various licensing methods (for Drugs, Biologics & Combination Products) by which applicants can file for product licenses (Marketing Authorizations) in one or multiple Member States, as well as fully across all Member States of the European Union. This course specifically outlines and discusses the structure of the regulatory agencies at the EU-level and across specific Member States. Course content will explain which procedures are available for which products and then will follow the license processing steps for each...
CONFERENCE
JUN
25
8:30 AM
Supplier Management for Medical Device Manufacturers
, San Diego, CA, USA
Course Description: Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide components to the device manufacturer, which means that they are critical to performance and delivery. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment. How well do you understand the requirements for supplier management? Could you pass a regulatory audit or inspection without any issues? This course...
CONFERENCE
JUN
25
8:30 AM
Import Procedures and Documentation
, Anaheim, CA, USA
Course Description: This 2-day seminar is designed to assist companies that import commercial shipments into the United States to better understand their obligations to take reasonable care in conducting business with U.S. Customs and Border Protection and other government agencies. The Customs Modernization Act has placed responsibility on the importer for proper entry, classification, valuation, and marking of imported merchandise. Failure to comply can result in penalties and fines, and in some cases both civil and/or criminal penalties. In addition, failure to comply with proper...
SEMINAR
JUL
09
8:30 AM
Compliance Processes for Life Science Products in Brazil, Russia, India, China markets
, Atlanta, GA, USA
Course Description: This seminar will help you understand the regulatory, quality and import / export requirements for Life Science Products in emerging markets - Brazil, Russia, India and China. Improved alignment to global standards was an important step forward toward foreign access, because it eliminated the conflicting standards that prevailed among provincial government agencies. Healthcare Authorities and regulatory systems have now made their requirements and procedures more transparent to industry partners. Clinical Trials can be conducted at a fraction of the expense. Structured...
CONFERENCE
JUL
09
8:30 AM
Technical and Regulatory Writing for FDA Regulated Industries
, Dallas, TX, USA
Course Description: Regulatory professionals have to write highly technical documents for a wide audience. These documents include reports, protocols, clinical trial and marketing approval applications, technical reports on studies, and communication documents. This workshop will address best practices, and regulatory strategies on how to write effective documents spanning everything from simple issues, such as minutes of meetings and correspondence notes, to highly sophisticated nonclinical and clinical study reports, and regulatory submissions to FDA, EMA, Health Canada, and other...
CONFERENCE
JUL
15
8:30 AM
OCEG approved GRC (Governance, Risk and Compliance) Professional Seminar
, Sydney NSW, Australia
Course Description: This GRC Professional Seminar will teach you how to efficiently design and enhance GRC activities within your organization based on established GRC standards and an internationally recognized framework. This program will enhance your credentials by helping you qualify for the GRC Professional certification exam, offered by GRC Certify. Through lectures, practical group interaction, discussions, and exercises, participants will learn to: Define a GRC strategy Integrate and improve corporate performance, and risk and compliance programs Strengthen core business...
CONFERENCE
AUG
26
8:30 AM
Anti-Corruption Compliance - Understanding the OECD Anti-Bribery Convention
, Dubai - Dubai - United Arab Emirates
Course Description: Bribery can often damage your business and your reputation. However, your business is not the only victim. The government and the society are affected more, and they are severely undermined by the weakened rule of law and damaged economic and social development. As such, governments are making anti-corruption programs an integral part of compliance. The OECD and its member countries see the core principle in fighting corruption rooted in the principle of free and fair competition. Each bribe offered or accepted compromises this principle. This two-day training course is...
SEMINAR
OCT
08
8:30 AM
Why is FDA at my facility, and what do I do during an inspection?: 2-day In-person Seminar
Courtyard Boston Cambridge, 777 Memorial Dr, Cambridge, MA 02139, USA
Course Description: This two day course will prepare firms for a quick, productive, and efficient FDA inspection. Included are segments on FDA Law, how to prepare for the inspection, how to prepare your subject matter experts (SME’s) to respond properly, and how to respond to an FDA 483 or Warning Letter. Case Studies and Templates are included. This course begins with a high level discussion about why FDA conducts inspections and the sanctions available to FDA for those companies who choose not to comply with FDA requirements. Next, we cover what to expect during the inspection,...
CONFERENCE
NOV
12
8:30 AM
Regulatory Crisis Management: Best Practices for Dealing with the Common Crisis Events
, Boston, MA, USA
Course Description: Unlike risk management, which involves managing potential and known threats of narrow scope, crisis management involves managing unknown threats during and after their occurrence. A crisis event, if not managed adequately and timely, could negatively affect the status of applications with the FDA, public image, and financial status of the company. The workshop on crisis management will allow participants to engage in a simulated, real-world crisis scenario that could put a company’s reputation, profitability and future into jeopardy. Participants will immerse...
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CONFERENCE
MAY
21
8:30 AM
Fostering Transparency and Accountability to Combat Money Laundering and Illicit Financial Flows
To be announced shortly, Coronationville, Johannesburg, 2093, South Africa
Course Description: The existence of various conventions such as the UNCAC and AUCPCC conventions to eliminate corruption and money laundering indicate consensus for concerted action to tackle corruption, and stem global money laundering and IFFs (illicit financial flows). However, the reality is that the tasks involved in combating these threats have become more complex. The minimum that state parties can do is to comply with their obligations, under the watchful monitoring of the citizens to whom they are accountable. At the same time, it is clear that state institutions are unlikely to be...
CONFERENCE
MAY
21
8:30 AM
FDA Scrutiny of Promotion and Advertising Practices
To be announced shortly, San Francisco, CA, USA
Course Description: If you go "off label" with advertising and promotion, you become embroiled in FDA's advertising and promotion requirements. For devices, the law is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments need to collaborate now more than ever before. Firms need to identify practical criteria to make marketing decisions. The big question is whether or not marketing managers and regulatory affairs managers will really try to reach common ground. FDA's Center for...
CONFERENCE
MAY
21
8:30 AM
eCTD Submissions of IND and NDA/BLA to the US FDA
To be announced shortly, Washington, DC, USA
Course Description: Soon FDA will stop accepting paper submissions of all kinds of applications. Despite there being extensive information available from FDA and other regulatory bodies regarding eCTD submission, creating one and submitting it through the electronic submission gateway (ESG) of the FDA, is a daunting task even for those proficient in computer systems and coding languages. The off-the-shelf software and consultations available are prohibitively expensive not only in the capital investment required but also in terms of the time needed for getting a submission...
SEMINAR
MAY
21
8:30 AM
Complete 1099, TIN Matching, B-Notice, FATCA and Nonresident Alien 1042-S Compliance Update
Grand Hyatt San Francisco 345 Stockton Street, San Francisco, CA, USA
Course Description: The average cost of a Notice of Proposed Penalty is estimated at US $150,000 including the penalty itself and the added costs for consultants, personnel, remediation of legacy records, etc. Compliance is far less expensive than the alternative. Are you in compliance with the regulations surrounding data collection, backup withholding and information reporting? How do you determine whether you can accept a W-9 from someone or if you must request a W-8 instead? What if you send them a 1099 when you should have sent them a Form 1042-S? How will you deal with an IRS...
SEMINAR
MAY
21
8:30 AM
Roadmap of California Medical Leaves - Ultimate Guide to PDL, FMLA, FEHA, SDI, CFRA, PFL, ADA
, San Francisco, CA, USA
Course Description: This comprehensive interactive training workshop will help clarify California specific leaves, how they interact with the Federal medical leaves and how to apply leaves accurately and consistently. The first day will focus specifically on the latter while a full ½ day will be focused on how to handle performance management issues when managing employees on Intermittent or Ongoing Medical Leaves. Why You Should Attend: This interactive training workshop will provide you real life strategies from an in-the-trenches medical leave management and HR Expert Witness. You will...
CONFERENCE
MAY
20
8:30 AM
Business Continuity and Scenario Planning: 2-Day Comprehensive Workshop
,
Aims: A 2-day intensive course on business continuity and scenario planning focused on the banking/ financial institution environment with a view to provide banking professionals with a firm foundation of the standards of best practices in the critical area of business continuity planning. The Basel Accords have raised the profile of operational risk. There are a range of challenges within the accords where financial service firms need to consider a wide range of complex issues including events that have not happened yet. One of the most crucial objectives of management is to learn how to...
CONFERENCE
MAY
18
8:30 AM
Operations Risk Management and Mitigation - from Assessment to Implementation
, Dubai - Dubai - United Arab Emirates
Aims This is an intensive course on Operational Risk Management & Mitigation – from assessing the operational risks to how to implementing a working, viable operational risk management system. Aimed at the financial services industry this course explores the Operational Risk Management (ORM) function and mitigation requirements as mandated in the Basel Accords. A key objective of this course is to move the participants beyond the operational risk compliance requirements set down in the Basel Accords to an understanding of managing operational risk as a value added proposition that can be...
WEBINAR
MAY
13
10:00 AM
How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation
Online Event, Palo Alto, CA, USA
This training program will discuss designing an effective cleanroom facility validation protocol and report, when and how to transition into the routine environmental monitoring processes, how to maintain a state of control within the cleanroom, and the routine environmental monitoring and excursion investigation processes. Why Should You Attend: This 90-minute training will provide participants an understanding of: The regulations guiding cleanroom facilities What constitutes an effective design Cleanroom classification How a cleanroom validation should be structured Routine...
WEBINAR
MAY
13
10:00 AM
Understand Your Fiduciary Responsibilities to Your Health and Retirement Plans
Online Event, Palo Alto, CA, USA
This webinar will focus on the key elements that employers need to know in order to avoid potential fiduciary liability under Employee Retirement Income Security Act (ERISA). It will cover who is a fiduciary, the responsibilities of fiduciaries and how to implement safeguards to reduce the potential for ERISA liability. Why Should You Attend: Every employer that sponsors a health or retirement plan is subject to ERISA requirements. It is critical that employers understand the required standard of conduct in order to reduce potential liabilities not only for themselves but for the executives...
WEBINAR
MAY
13
10:00 AM
HIPAA and Business Associates - New Responsibilities and Obligations
Online Event, Palo Alto, CA, USA
This webinar will discuss the significant changes to the HIPAA rules for business associates, the new challenges for HIPAA covered entities and business associates, and new risks for non-compliance and penalties. Why Should You Attend: Since the new regulations have expanded the obligations of HIPAA business associates, it is now more important than ever to carefully consider whether a BA designation is appropriate or not – business associate agreements are not to be entered into lightly. The new requirements have a direct impact on what needs to be put into the business associate...
WEBINAR
MAY
12
11:00 AM
How to Develop a Medical Device Design Control Program that Will Meet FDA Requirements
Online Event, Palo Alto, CA, USA
This training program will offer attendees an understanding of the reasons for design control and highlight the key elements of a design control program. The FDA has concluded that a well-controlled design process with risk analysis, change control, design reviews and hardware/ software validation will greatly reduce the chances of an unsafe product. In accordance with the same, This webinar will also discuss how risk management fits into design control compliance. Why Should You Attend: This course will explain how to setup and manage a design program that will meet FDA requirements and...
WEBINAR
MAY
12
11:00 AM
Sales and Use Tax - Avoiding Double Tax on Drop Shipments
Online Event, Palo Alto, CA, USA
This webinar will discuss the principles of drop shipment exemption. It will also detail how you can help your company legally avoid tax assessments by your drop shippers on your resale orders. Why Should You Attend: Drop shippers everywhere are falling prey to state auditors who charge them tax when shipping into their states on behalf of retailers who don’t have nexus there. Retailers claim resale exemption. How can the retailer satisfy the drop shipper and the state auditor? Through this course, get up to speed on the most complex national sales tax issue and what it takes to comply...
WEBINAR
MAY
12
10:00 AM
I-9 Form Immigration Compliance - Is Your Company Ready for ICE?
Online Event, Palo Alto, CA, USA
This training program on I-9 form immigration compliance will discuss an organization’s preparedness for ICE inspections. It will detail compliance requirements and penalties for non-compliance along with course of action on receipt of Notice of Inspection from ICE. Why Should You Attend: With chances of being inspected and fined by ICE growing every year, this webinar will impart important information on immigration compliance – correctly completing an I-9 form, how to correct errors on I-9 forms, agency decisions on penalties and what happens if your company receives a Notice of...
WEBINAR
MAY
12
10:00 AM
Payroll Tax Records: What to Keep, What to Toss and who are accountable
Online Event, Palo Alto, CA, USA
Businesses often unwittingly commit payroll fraud when they are unaware of payroll tax laws and procedures to maintain payroll records. There can be heavy penalties assessed, fines assessed, and even jail time for payroll tax fraud. This webinar will illustrate federal and state requirements that need to be complied with in maintaining payroll records. It will further highlight several areas of concern and challenges faced by businesses and business owners in handling government contract requirements and tax forms. Why Should You Attend: Some businesses, especially new businesses, small...
WEBINAR
MAY
12
10:00 AM
Establishing and Executing an UDI Program for IVDs
Online Event, Palo Alto, CA, USA
This training program will assist participants in fully comprehending the FDA UDI requirements. IVDs present unique challenges in implementing UDI programs because the marketed IVD includes multiple components needed to use the IVD according to labeled instructions. This webinar will help attendees begin the process. Why Should You Attend: This webinar will guide participants in: Fully understanding US FDA UDI requirements Developing a sense of how to start UDI for an international product Developing an understanding of the interaction between departments needed to realize a UDI...
WEBINAR
MAY
12
10:00 AM
Internal Control Design and Implementation
Online Event, Palo Alto, CA, USA
Internal controls are ambiguous, yet they are vital to the health of an organization. In this training program, participants will learn the distinction between job processes and the internal controls that regulate them, and basic techniques to enhance controls to achieve the organization’s objectives. Why Should You Attend: Internal controls are necessary in every aspect of business operations to ensure that a company achieves its business objectives while minimizing risks. Management and the board of directors are responsible for the organization’s system of internal controls, and...
WEBINAR
MAY
12
10:00 AM
FDA vs. EU Inspections - Getting Prepared and What are Differences
Online Event, Palo Alto, CA, USA
This webinar will help attendees understand the FDA and EU inspection process and how to prepare for both of them. Attendees will learn the best practices to respond to Form 483 citations, Warning Letters and EU inspection findings. Why Should You Attend: FDA and EU GCP regulations and standards apply to pharmaceuticals, IVDs and medical devices. Failure to conform to these requirements may result in concerns about quality and integrity. Inspections are critical to the success of business on several levels. Therefore, being appropriately prepared and management of the inspection and audit...
CONFERENCE
MAY
11
8:30 AM
Operations Risk Management and Mitigation - from Assessment to Implementation
, London, UK
Aims Recently, a series of headline-grabbing operational risk incidents at banks, other financial institutions and even regulators have again brought the issue of operational risk management to the forefront of the agendas of CEOs, CROs, risk managers and internal and external auditors alike. These incidents are wide ranging and flow from bank ATM collapses, bank operating system failures, regulatory settlements in the ongoing US sub-prime mortgage saga, rogue traders and the connected risk managers who either missed or were willfully blind to all the warning signs. As the size and...
CONFERENCE
MAY
07
8:30 AM
Effective Audit Report Writing: 2-day In-person Seminar
, Chicago, IL, USA
Course Description: The audit report represents the end result of weeks of reviews, analyses, interviews and discussions. It is used to provide information to management on the area you reviewed. And, more importantly, the report brings issues to their attention that needs to be addressed. How well you communicate that information is critical to getting the results you are seeking. The keys to an effective audit report are: Knowing your reader and how to craft an audit report that will get their attention. Understanding the IIA Standards for report writing Developing the best audit...
WEBINAR
APR
29
10:00 AM
The Affordable Care Act: Key Compliance Issues for Employers in 2015 and Beyond
Online Event, Palo Alto, CA, USA
This training program will focus on ACA compliance requirements for 2015. It will also cover topics such as anti-discrimination provisions for highly compensated employees, affordable coverage penalty, transitional relief for some employers in 2015, and more. Why Should You Attend: This year the rubber really meets the road for Affordable Care Act compliance. Yet many, whether they are simply concerned individuals or business owners or executives, still find the ACA to be a topic that generates much confusion. This webinar will de-mystify key ACA issues. If you are an employer, HR...
WEBINAR
APR
29
10:00 AM
Latest Requirements for Informed Consent Content and Process Requirements
Online Event, Palo Alto, CA, USA
This training program will guide participants on how to create and use patient information consent forms, and generate a system for training and implementation of effective and compliant informed procedures. This webinar will assist participants in preparing for inspection of the informed consent process. The course will also discuss the impact of the inspections of the informed consent process on the ethics and integrity of the data collected. Why Should You Attend: This webinar will help sponsors and CROs in the US, EU and internationally understand how to ensure the content and process...
WEBINAR
APR
29
10:00 AM
National Practitioner Data Bank: Do You Know What it Says About You?
Online Event, Palo Alto, CA, USA
This training program will offer attendees insight into using the National Practitioner Data Bank (NPDB). Hospitals are required to query the NPDB before granting privileges to a practitioner and before renewing those privileges. The information maintained by the NPDB could have serious implications for a practitioner seeking privileges or licensure. Why Should You Attend: It is critical for physicians and other practitioners to ensure that the information maintained by the NPDB is accurate. This webinar will provide information about how to access the NPDB information and how to correct...
WEBINAR
APR
29
10:00 AM
Foreign Corrupt Practices Act (FCPA) and International Anti-Bribery Course
Online Event, Palo Alto, CA, USA
This training program will cover the requirements of the Foreign Corrupt Practices Act (FCPA) and other national and international anti-bribery laws and treaty provisions. The webinar is part of a two-course training session, where the first segment will help attendees understand the provisions of the FCPA and other foreign anti-bribery laws, as well as those actions that are exempt from prosecution and where this second segment will test participants’ understanding of these laws using practical examples, real cases and enforcement actions, such as those involving U.S. retailers,...
WEBINAR
APR
28
11:00 AM
How Audit Evaluation Can Ensure Effective Decision Making Under Uncertainty
Online Event, Palo Alto, CA, USA
This presentation will explore the nature of decision making in crisis situations. It will explore the psychology of decision making under stress and overview risk management analysis tools. The webinar instructor will present tips and techniques to identify structural and cyclical changes, improve risk management strategy processes, and identify transparent vulnerabilities. Why Should You Attend: The webinar will emphasize the different stages that employees go through before taking action in a crisis. Building on this understanding, the instructor will illustrate to participants how best...
WEBINAR
APR
28
10:00 AM
Trade Patterns and Methods for Conducting International Trade to Mitigate Risk
Online Event, Palo Alto, CA, USA
This training program will contemplate the increase in global trade and the resultant need for organizations to understand how to grow their bottom line while minimizing risk when importing or exporting. Companies of all sizes are recognizing the advantages of buying and selling outside their domestic market. While there are more risks in international trade than there are in domestic trade, there are also more revenue opportunities as well as effective methods for mitigating risk. Why Should You Attend: Increasing globalization has led to the need to explore the opportunities afforded by...
WEBINAR
APR
28
10:00 AM
Using Kanban/JIT Systems and Lean Elements to Run a Startup Plant
Online Event, Palo Alto, CA, USA
This training program is essential for those introducing lean principles at the company’s earliest stages. A startup plant faces many challenges and options. Too often, the brainpower and focus is on the science and technology of the product. However, without agile systems from the earliest stages, the company may struggle for the wrong reasons as it tries to ramp up its manufacturing and quality systems. Why Should You Attend: This webinar will explain how to set up and use kanbans all the way from purchasing and procurement, to receiving, receiving inspection, component stock, work...
WEBINAR
APR
28
10:00 AM
Performing an Effective, Robust and Compliant Sterility Failure Investigation
Online Event, Palo Alto, CA, USA
This training program will highlight mistakes often made when corrective and preventative actions are not clearly identified and applied during a manufactured product sterility test failure investigation because an ineffective investigational procedure and tool was used to conduct a sterility test failure investigation. The webinar will also illustrate how avoiding such common mistakes will ensure that these types of products meet the sterility requirements USP and other regulatory guidelines applicable to finished products, bulk drug substance, raw materials or excipients. Why Should You...
WEBINAR
APR
28
10:00 AM
Employee Expense Reimbursement Fraud: Detection, Prevention and Deterrence
Online Event, Palo Alto, CA, USA
This 90-minute webinar will summarize the main types of reimbursement fraud to be alert to, and include an analysis of several “real life” case studies. It will explain how to identify the red flags of possible reimbursement fraud, offer specific fraud-audit techniques and test for these crimes and conclude with a rundown of proven anti-fraud controls. Why Should You Attend: Employees who have the opportunity to exploit weaknesses in your organization’s expense reimbursement processes and procedures can do so. Moreover, anti-fraud experts agree that expense reimbursement fraud can be...
WEBINAR
APR
27
10:00 AM
Using Requirements Management to Ensure Compliance
Online Event, Palo Alto, CA, USA
This training program will elaborate how best to employ requirements management to ensure compliance with FDA's design control requirements. Requirements management involves managing versions of requirements and the relationship between requirements and the project deliverables. Using this model as a best practice can result in a more robust design control process and minimize FDA observations. Why Should You Attend: There is a wide variation of how the medical device industry manages requirements. This presentation will cover a requirements management approach consistent with the CMMi...
WEBINAR
APR
27
10:00 AM
ICH Q10 - Moving From GMPs To A Pharmaceutical Quality System
Online Event, Palo Alto, CA, USA
This ICH Q10 training /webinar will discuss the evolution and interpretation of the pharmaceutical GMPs as a quality control regulation to the Quality Assurance emphasis of the Pharmaceutical Quality System as defined in ICH Q10. Why Should You Attend: Since the release of the Quality System Regulation for medical devices, the FDA has been trying to transition the pharmaceutical industry to a Quality System approach to compliance. The issuance of the Guidance for the Industry: Quality System Approach to Pharmaceutical CGMPS and ICH Q10. Pharmaceutical Quality System has brought new focus to...
WEBINAR
APR
27
10:00 AM
UI Taxes - Managing Unemployment Insurance Costs
Online Event, Palo Alto, CA, USA
This training program will provide an update of key federal and state unemployment issues. Participants will gain an understanding of the critical issues affecting their individual UI accounts and develop methods to control UI costs and manage other related liabilities. Why Should You Attend: Employer paid unemployment insurance taxes and costs, once a nuisance expense, have increased significantly in recent years. In some states employers’ UI tax liabilities have increased by more than 300 percent as states have increased UI experience rates, increased taxable wages bases, and imposed...
WEBINAR
APR
24
10:00 AM
Performing Safety, Accident, and Workers Comp Investigations
Online Event, Palo Alto, CA, USA
When an accident happens, some degree of confusion generally follows. An employer has compliance obligations that its investigations are thorough, objective, and professional and an honest attempt to fulfill its obligations to employees to provide a safe place to work. Without a trained investigator performing investigations, such quality investigation becomes much less likely. In an accident with injury, it may also be necessary to review the validity of workers compensation claim(s). This training program will focus on safety investigations and the interplay between OHSA and Workers...
WEBINAR
APR
24
10:00 AM
How to Prepare a Customs Compliance Manual
Online Event, Palo Alto, CA, USA
This webinar will explain how to prepare a Customs manual that complies with CBP laws and regulations. Attendees will learn best practices for successfully passing an audit or becoming an Importer Self Assessment Program (ISA) member. Why Should You Attend: You know that your company has good procedures in place for compliance with applicable Customs laws and regulations, but these procedures are not well documented. Perhaps the U.S. Customs & Border Protection (CBP) has just informed you that your company will be audited in the near future, or you have decided to apply for membership in...
WEBINAR
APR
24
10:00 AM
Use Risk Assessment to Reduce Validation Time for 21 CFR Part 11
Online Event, Palo Alto, CA, USA
Get a detailed understanding of how to perform risk assessment as part of the 10-step risk based approach to CSV. Why Should You Attend: In this webinar, participants will learn how to perform risk assessment as part of the 10-step risk-based approach to computer system validation. This distinct approach will help minimize project time by employing fill-in-the-blank templates. You can ensure compliance with QA, FDA, and clients. The instructor will use examples and real time scenarios to better illustrate the application of the techniques for any validation project. Areas Covered in the...
WEBINAR
APR
23
11:00 AM
FDA Accession Numbers
Online Event, Palo Alto, CA, USA
This training program will detail how FDA import entry specialists use the FDA accession number to identify the product being imported. FDA requires importers to complete FDA Form 2877, which has a section for the FDA accession number to be listed. This webinar will list importer responsibilities and instruct attendees on how to adequately complete the FDA Form 2877. Why Should You Attend: Like most government forms, FDA 2877 (Declaration for Imported Electronic Products Subject to Radiation Control Standards) comes with a stern warning to the importer: Any person who knowingly makes a...
WEBINAR
APR
23
10:00 AM
Complaint Handling in Compliance with FDA and ISO Regulations
Online Event, Palo Alto, CA, USA
This training will detail how you can handle customer complaints in compliance with FDA and ISO regulations. The instructor will discuss topics like best practices for documenting customer feedback, what constitutes a complaint, what to do with non-complaint feedback, and how to include complaint trending into your firm’s CAPA program. Why You Should Attend: Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO...
WEBINAR
APR
23
10:00 AM
Compliant and Effective Recruiting Including Compliance Challenges
Online Event, Palo Alto, CA, USA
This course will highlight the key components of an effective and compliant recruiting process and discuss federal and state regulations that impact recruiting. The webinar instructor, a senior human resource executive and business strategist, will also analyze the challenges in passive candidate recruiting. Why Should You Attend: Posting a job, reviewing candidates and moving them through the hiring process are the standard approach to recruiting. How effective is this process in bringing the right talent into your firm? How can you improve the effectiveness and compliance of a...
WEBINAR
APR
23
10:00 AM
How to Contest IRS Penalty and Interest Determinations
Online Event, Palo Alto, CA, USA
Tax practice and the resolution of tax problems with the IRS can be tedious and challenging. This course will show practitioners how to navigate through the confusing IRS system and enable them to ensure that their clients receive all the rights to which they are entitled. Why Should You Attend: On completing this course, participants will be able to: Understand how to avoid making major mistakes in dealing with the Internal Revenue Service Guide clients with the best advice Determine how to legally reduce clients’ tax, penalty, and interest liabilities Areas Covered in the...
WEBINAR
APR
23
10:00 AM
Legal and Effective Behavioral Interviewing
Online Event, Palo Alto, CA, USA
In this webinar, HR professionals, and managers can learn how to prepare, conduct, and evaluate behavioral interviews when hiring or promoting employees; to eliminate subjective hiring decisions and increase effectiveness and validity in the selection process while following legal guidelines. Why Should You Attend: Have you ever been completely blind-sided by a job candidate? In the interview he seemed perfect; once hired, he was a disaster. In this program, Judi addresses both the art and science of effective behavior interviewing. You’ll learn how to prepare for an interview and ask...
WEBINAR
APR
23
10:00 AM
Procure to Pay (P2P) Fraud
Online Event, Palo Alto, CA, USA
This unique and interactive workshop will analyze real time case studies from all components of the procure to pay (P2P) process that include: procurement, T&E;, P-Card, AP, and disbursements. Attendees will have an opportunity to discuss what went wrong and will determine the key internal controls that were missing. The instructor will highlight the three critical corporate controls, the standards of internal control for P2P, and the top twenty controls for AP. Why Should You Attend: Purchase to pay process, compliance controls, segregation of responsibilities – all things which to a...
WEBINAR
APR
23
10:00 AM
Performing Your ACH Audit: The Ins and Outs of ACH Rule Compliance
Online Event, Palo Alto, CA, USA
The NACHA Operating Rules and Guidelines require that all participating depository financial institutions, third-party senders and third-party service providers that provide ACH services conduct an annual ACH audit to be performed by December 31 of each year (ACH Rules, Appendix Eight, Section 8.1). It is critical that electronic payments work safely and efficiently for all users. The ACH network strives for just that by requiring the annual ACH audit. This webinar will offer attendees a keen understanding of general audit requirements, and the functions of a receiving depository financial...
CONFERENCE
APR
23
8:30 AM
How to Prepare for an FDA Meeting: Making the Most of Pre-IND/IDE
, Chicago, IL, USA
Course Description: Despite a few guidance documents to help sponsors prepare for meetings with the FDA, it is a challenge to understand the most efficient and productive ways to strategize, prepare, conduct, and follow-up for these meetings. There are many misconceptions about the expectations from these meetings both for the sponsor and the FDA, and hence many sponsors fail to get the most benefit from them. Over the years, the FDA has also revised processes and practices for meeting with sponsors. This two day seminar will provide valuable tips about the logistics, planning, conduct and...
CONFERENCE
APR
23
8:30 AM
Reducing Taxes and Managing Accounting for Efficient Business Investments
, San Diego, CA, USA
Course Description: This course will: Explain tax planning and accounting for common investments, including businesses, marketable securities and real estate Detail the reasons to run a business or invest using several legal structures that are available: proprietorship, S or C corporation, LLCs or disregarded entities Discourse how to protect your assets from legal claims and employee theft Enumerate how to reduce the number of tax returns that must be filed through the use of series LLCs and disregarded entities Provide suggestions on setting up record keeping and accounting systems...
SEMINAR
APR
23
8:30 AM
Building a Sustainable Validation Program from Top to Bottom: One and a Half Day In-Person Seminar
, Orlando, FL, USA
Course Description: Companies face many common issues and confusion when creating or revamping their validation programs. Some of them include: While an organization has ample experience in perfecting its process validation program, it may not be able to get its arms around the facility and equipment changes that require never ending equipment qualification (IQ, OQ, PQ). Customer or 483 audit findings require the company to deviate from its own validation program to meet the needs of the FDA or the customer. For systems that employ software and hardware,...
WEBINAR
APR
22
10:00 AM
Global and FDA Regulation of Electronic Cigarettes
Online Event, Palo Alto, CA, USA
The global regulatory environment for tobacco, e-cigarette and e-liquid products is rapidly evolving as legislators and regulators in the United States, European Union and Asia attempt to understand the health and safety concerns presented by these novel products, and develop appropriately tailored laws and regulations. This training course will present an overview of e-cigarette regulations in Asia, the European Union and around the world. It will also detail the key provisions of FDA’s deeming regulations. Why Should You Attend: This session will review the legal status of these...
WEBINAR
APR
22
10:00 AM
Laboratory Investigation Out-of-Specification Results
Online Event, Palo Alto, CA, USA
In this 90-minute training on laboratory Out-of-specification (OOS) investigations, you will learn what constitutes an OOS observation, what is the OOS investigation process described in the OOS guidance and steps to be taken in the laboratory in the event of an OOS observation. Why Should You Attend: Inadequate procedures for laboratory Out-of-specification (OOS) investigations remain high on the list of FDA observations. The FDA has issued a guidance on the topic. OOS procedures and investigations are still a topic of FDA Investigator review and findings. An out-of-specification...
WEBINAR
APR
22
10:00 AM
Qualified vs. Non-Qualified Deferred Compensation Plan
Online Event, Palo Alto, CA, USA
This presentation will provide you with a good foundation to help you design and administer these nonqualified deferred compensation plans in a legally compliant manner. You will learn the differences between qualified and non-qualified plans, ERISA, 409A & Govt. filing requirments. Why Should You Attend: Nonqualified deferred compensation plans can provide executives with benefits in excess of those provided under qualified deferred compensation plans. While attractive to executives, these plans are subject to complex rules. It is critical that employers understand and properly implement...
WEBINAR
APR
22
10:00 AM
HIPAA Security and Breach Notification Rules - Protecting Security of PHI
Online Event, Palo Alto, CA, USA
Staying HIPAA compliant entails ensuring you have the right policies, procedures, and documentation, and have performed the appropriate risk analysis of confidentiality, integrity, and availability of the electronic protected health information (PHI). This course will discuss how to create the right breach notification policy for your organization and how to follow through when an incident occurs. In addition, a policy framework to help establish good security practices will be presented. Why Should You Attend: Having a solid information security management process is key to ensuring you...
WEBINAR
APR
22
10:00 AM
The Most Serious FDA 483s - How to Avoid Them
Online Event, Palo Alto, CA, USA
This webinar on avoiding serious FDA 483s will explain FDA's changed audit focus based on recent top 483 findings and provide practical tips on how to better prepare your company's internal audit program to avoid serious Form 483 observations. Why Should You Attend: Recent FDA audits indicate a shift in the top serious Form 483 observations. This webinar will evaluate the chief areas of FDA CGMP compliance audits based on recent top 483 findings to see actual and anticipated changes in emphasis, and how to better prepare with a company's internal audit program . This 90-minute session...
WEBINAR
APR
22
9:00 AM
Clinical Laboratory Improvement Amendments
Online Event, Palo Alto, CA, USA
This Clinical Laboratory Improvement Amendments (CLIA) training will be valuable to CLIA regulated, non-waived laboratories that run automated analyzers or semi-quantitative kit tests. It will highlight differences between quality control and quality assessment and the proper methods to meet CLIA guidelines. Why Should You Attend: AS CLIA evolves, so must the laboratory. The rules and regulations governing how quality is measured in the lab and how quality control is performed have changed over time. New requirements make it essential that you understand mindset of CLIA, and what they...
WEBINAR
APR
21
10:00 AM
HR Audits: Identifying Critical Management Issues
Online Event, Palo Alto, CA, USA
This training program will cover key HR capital issues. It will emphasize key areas that should be addressed in conducting an HR audit, offer an understanding of critical tasks to be completed, and detail how federal and state employment laws may affect the scope and reporting of the HR audit. Why Should You Attend: This webinar will provide advanced training in planning, executing, and reporting HR audits. Critical HR audit issues will be reviewed including: Developing an HR audit plan Identifying audit stakeholders Critical employment practice areas Analyzing key performance and...
WEBINAR
APR
21
10:00 AM
Do You Really Need To Do A Recall? If So, What Is Required?
Online Event, Palo Alto, CA, USA
This training program will provide practical pointers on documenting the recall decision. Recall can be a very costly process for a manufacturer. It is really important from a regulatory perspective to properly document the decision process whether a recall is necessary or not. The new guidance can help provide some direction in making the decision. Though guidance documents are not binding, they do tend to reflect the current thinking of the FDA. Beyond the guidance, the webinar will also illustrate best practices for documenting the recall process in the event that you determine a recall is...
WEBINAR
APR
21
10:00 AM
Validation of Analytical Methods According to the New FDA Guidance
Online Event, Palo Alto, CA, USA
This webinar will elaborate the scope and content of the recent FDA guidance on validation of analytical methods. The webinar will also illustrate the lifecycle management of analytical procedures and train attendees on documentation requirements and verification of submitted methods. Why Should You Attend: Recently the FDA has released a new comprehensive guidance for validation of analytical methods. The guidance applies the modern integrated lifecycle approach with related new requirements for using quality-by-design components, risk assessment, design space and continuous improvement....
WEBINAR
APR
21
10:00 AM
Developing an Effective Fraud Risk Management Program
Online Event, Palo Alto, CA, USA
The risk of fraud is just one of the many types of risks to be managed by an organization. But to let this risk fall out of focus can bring catastrophic results. Building an effective fraud risk management program to combat organizational fraud requires solid understanding of how and why fraud is perpetrated. This course will discuss the components of a fraudulent act, different types of fraud schemes and the impact fraud has on organizations. It will also analyze why individuals commit fraud and why the threat of punishment alone doesn’t deter potential fraudsters. Why Should You...
WEBINAR
APR
21
8:00 AM
Fraud in Clinical Research
Online Event, Palo Alto, CA, USA
This training program will instruct attendees to better understand ethical and legal requirements when conducting medical/clinical research and study. The webinar will focus on what/how to identify, address and prevent fraud in medical research. Why Should You Attend: Fraud in medical research has a long, documented history. This webinar will discuss fraud in medical research to greatly improve attendees’ awareness about recent fraud in medical study and research. In particular, it is intended to help industry understand ethical and legal requirements when conducting medical research. The...
WEBINAR
APR
17
10:00 AM
Introduction to Tariff Classification: Are Your Products Classified Correctly?
Online Event, Palo Alto, CA, USA
This training program will discuss why the role of Harmonized System (HS) classification is crucial to the import process. The HS classification is a multipurpose, global classification tool developed and maintained by the World Customs Organization. It is used by customs agencies around the world to classify the products entering a country’s borders and forms the basis for the customs tariff of 179 countries. In fact, most countries consider the misclassification of products to be a trade violation; making tariff classification a major trade compliance issue. Why Should You...
WEBINAR
APR
17
10:00 AM
FMLA Abuse: How to Identify, Investigate, Deny, and Terminate
Online Event, Palo Alto, CA, USA
This webinar will assist employers with effective strategies to identify, investigate, and terminate FMLA abusers. Additionally, the course will also instruct employers on when it is appropriate to deny FMLA requests in accordance with the law. Why Should You Attend: This webinar will instruct attendees on FMLA compliance and educate employers on identifying and eliminating FMLA leave abuse among employees. The employment law compliance expert will also focus on key elements like: Maintaining an updated employee leave policy Calculating leave entitlement and intermittent leave ...
WEBINAR
APR
17
10:00 AM
Social Media Risks, Rules, Policies and Procedures
Online Event, Palo Alto, CA, USA
This social media training program with Nancy Flynn will reveal how a best practices-based policy and compliance management program can help mitigate risks, manage behavior, and maximize compliance. It will discuss means and methods to recognize and manage social media risks. Attendees will learn how a strategic social media management program-combining policy, training, and technology-can help prevent potentially costly legal, regulatory and security disasters. The course is a must for anyone who wants to ensure that business, personal, and public social media are managed and maintained in...
WEBINAR
APR
17
10:00 AM
Hazardous Waste Regulation
Online Event, Palo Alto, CA, USA
This training program will offer a comparison of RCRA and California hazardous waste characterization. It will detail the enactment of the California Hazardous Waste Control Law in 1972 before RCRA in 1976. The course will also discuss permits required to treat most hazardous wastes that would be exempt from permitting under RCRA. Why Should You Attend: California has unique hazardous waste regulations that include, but substantially exceed requirements of the federal Resource Conservation and Recovery Act (RCRA) regulations generally in effect in other states. It is also hard to navigate...
WEBINAR
APR
16
11:00 AM
How to Prepare an Effective Audit Manual for an Internal Audit Department
Online Event, Palo Alto, CA, USA
This webinar will instruct attendees on how to develop an internal audit manual and offer start to finish instructions and templates on how to perform different types of audits given the project description. Audit fieldwork, audit reporting and follow-up, work-paper filing, and project closure are some of the other areas the webinar will cover. Why Should You Attend: An audit manual is essential for adequate documentation and to ensure that the necessary steps to take during an audit are adhered to in keeping with the internal audit standards as promulgated by the Institute of Internal...
WEBINAR
APR
16
10:00 AM
How to Manage an Effective AML Audit Program
Online Event, Palo Alto, CA, USA
This webinar will highlight the techniques and best practices that can be used for conducting an effective AML audit in order to ensure compliance with Bank Secrecy Act (BSA) regulations. Why Should You Attend: Financial institutions are continually evolving their systems and processes, and some continue to be challenged by risks associated with conducting an inadequate audit. Recent actions have brought forth regulatory criticisms for inadequate scoping and testing of audits. With more scrutiny placed on internal audit to have deep expertise in BSA/AML, many financial institutions are...
WEBINAR
APR
16
10:00 AM
OSHA Record Keeping Compliance
Online Event, Palo Alto, CA, USA
This OSHA Recordkeeping training will cover critical aspects of OSHA recordkeeping and its requirements, to be compliant with OSHA regulations. Why Should You Attend: Those responsible for maintaining filling out and recording injuries and illnesses are often confused by what should and should not be included in the OSHA recordkeeping forms. Over-reporting injuries and illnesses can be as serious as under-reporting injuries and illnesses, and can even lead to uncomfortable OSHA inquiries or even inspections. It is also difficult to know how to accurately account for time lost due to...
WEBINAR
APR
16
10:00 AM
Pharmaceutical Compressed Air - Quality GMP Standards and Requirements
Online Event, Palo Alto, CA, USA
This webinar will take you through the primary sources of compressed air contamination. It will also detail GMP standards and requirements pertaining to compressed air quality. Why Should You Attend: Compressed air is often overlooked as a potential source of clean room and product contamination. This webinar will give you an understanding of the different types of contamination inherent in compressed air and how to prevent each from affecting your particular system. A detailed description of a typical pharmaceutical compressed air system with its individual components will be provided....
WEBINAR
APR
16
10:00 AM
Bulletproof Workplace Investigations
Online Event, Palo Alto, CA, USA
This webinar will train attendees on carrying out effective and lawful workplace investigations. Human resources managers and others charged with conducting workplace investigations will learn effective strategies for investigating complaints made by or against an employee. This webinar will offer guidance on how best to proceed and how to achieve a meaningful outcome for all involved. Why Should You Attend: When it comes to employee investigations, it’s all about the W’s – Who, What, When and Why. Asking crucial questions, seeking key information and documenting your findings make...
CONFERENCE
APR
16
8:30 AM
GMP Compliance for Quality Control and Contract Laboratories: 2-day In-person Seminar
, Boston, MA, USA
Course Description: Quality control and related contract laboratories are considered at high risk because after testing and approval, drug products and Active Pharmaceutical Ingredients (APIs) are released to the market without further check. That's the reason why the FDA and other agencies put highest emphasis on inspections of QC laboratories. Even though cGMP regulations have been in place since long time, the large number of QC related 483's and warning letters demonstrate that companies have problems with implementation. This two day interactive in-person seminar will provide...
CONFERENCE
APR
16
8:30 AM
Change Control Best Practices - Avoiding Unintended Consequences of Changes
, Boston, MA, USA
Course Description: With FDA citing inadequate change control constantly in its 483s and Warning Letters, the prerequisite to ensure that changes are accurately described, justified, assessed for risk, implemented, and documented has come to the fore. Changes must also be prospectively reviewed by appropriate subject matter experts. Furthermore, certain major changes (e.g. manufacturing, specifications) may require regulatory filings and/or prior regulatory approval. This seminar will guide all personnel involved in proposing, assessing, and implementing changes to understand and...
SEMINAR
APR
16
8:30 AM
Navigating through Maze of In-vitro Diagnostics (IVD)
, Philadelphia, PA, USA
Course Description: In-vitro Diagnostics (IVD) products provide critical information on patient’s health condition, based on which the healthcare provider develops and administers treatment plan. Although IVDs are medical devices, they are regulated under a separate set of regulations in U.S., Europe, and Canada. This 2 day interactive course on in-vitro diagnostics is structured to understand the different set of IVD regulations, how to navigate through this maze of IVD regulations, and to win regulatory approvals. This In-vitro Diagnostics (IVD ) course will make the...
WEBINAR
APR
15
10:00 AM
U.S. Payments Landscape
Online Event, Palo Alto, CA, USA
Different payment approaches are starting to remove the requirement for a payment card at the point-of-sale (POS), leveraging cloud-based services or mobile devices. This training program will enumerate how significant changes in the U.S. payments landscape are effecting how merchants accept payments. Why Should You Attend: This webinar will offer attendees an in-depth understanding of what payment brands have announced in U.S. liability shift for domestic and cross-border counterfeit card-present POS transactions, effective October 1, 2015. The payment brands have also used various...
WEBINAR
APR
15
9:00 AM
Nonresident Alien Vendors
Online Event, Palo Alto, CA, USA
Collecting the tax due from NRAs (nonresident aliens) working in the U.S. is a Tier 1 audit issue. This tax burden is minimized when companies making payments to NRAs for dependent and independent personal services properly withhold on these payments. This training program will review the five forms W-8 including the new W-8BEN-E just released in Q1-2014. It will help attendees establish which W-8 to provide NRAs working for them. Why Should You Attend: How do you know whether you can accept a W-9 from someone or you must request a W-8 instead? What if you send them a 1099 when you...
WEBINAR
APR
14
10:00 AM
Form W-4 for 2015: Best Practice and Compliance Requirements
Online Event, Palo Alto, CA, USA
The payroll department frequently has questions regarding processing Form W-4s. Failure to complete the forms accurately can lead to costly expenditures of time and budget resources. This webinar will discuss the 2015 Form W-4 and the IRS’ requirements for completing, processing, submitting and correcting the form. Why Should You Attend: Is it a valid form? If not, what should payroll do to correct the problem? Can the employee request a flat dollar amount on the form? Can the form designate a percentage of wages for taxes? The answer to these questions could very well be the key...
WEBINAR
APR
14
10:00 AM
Particulates in Biological products
Online Event, Palo Alto, CA, USA
This webinar will discuss the evolving regulatory requirments for testing Biologics injectibles for sub-visible Particulates. Why Should You Attend: There is an increased scrutiny on the testing and reporting of particulates in Protein Therapeutics. Proteinaceous Particulates in Biologics injectibles can arise from the aggregation of the protein product and can be induced by silicone droplets, metal particles and glass particles. Aggregates in protein products present a safety concern because they may increase the immunogenicity of the product. The FDA has therefore requested BLA sponsors...
WEBINAR
APR
14
10:00 AM
South East Asia Regulatory Compliance for Life Science Products
Online Event, Palo Alto, CA, USA
This training on South East Asia regulatory compliance for life science products will discuss the regulatory structure and requirements for compliance with in-country regulations for pharmaceuticals, medical devices, biologics and combination products. This webinar will focus on a high-level composite of requirements in Taiwan, Hong Kong, Singapore, Malaysia, Vietnam & Thailand. Why Should You Attend: The South East Asian markets are growing in importance and interest in access to innovative products. In-country regulatory agencies are progressing in their sophistication, process...
WEBINAR
APR
14
1:00 AM
Good Laboratory Practices for Food Manufacturing
Online Event, Palo Alto, CA, USA
Food manufacturers and food processors are constantly collecting data for quality analysis. This data collection process often needs to be analyzed. GLPs are used for data collection and data quality. It is not to be confused with laboratory safety (such as PPE). This training session will focus on fundamental areas of focus of GLP, the history of GLP principles, and the importance of compliance with GLP regulations. Why Should You Attend: This session is designed for manufacturers interested in learning more about the fundamentals of good lab practices for food manufacturing. Regulatory...
WEBINAR
APR
13
11:00 AM
Offensive Behavior and Harassment that Violates Title VII of the Civil Rights Act of 1964
Online Event, Palo Alto, CA, USA
Employee complaints go with the territory when you are a manager. But how do you know when your complaints and concerns may indicate policy violations or illegal behavior? This webinar will help attendees understand the definitions of harassment and offensive behavior, protected classes, the supervisor’s role, and preventing retaliation. Why Should You Attend: Our increasingly diverse workforce increases the chances of misunderstandings, and potential mistreatment, of fellow employees. Whether harassment or offensive behavior is intentional or not, the supervisor has legal obligations to...
CONFERENCE
APR
13
8:30 AM
Analytical Instrument Qualification and System Validation: 2- day In-person Seminar
, San Diego, CA, USA
Course Description: Analytical instruments should be qualified and systems should be validated to demonstrate suitability for the intended use. This two day in-person seminar will provide attendees the regulatory background and guidance through the complete process from planning and writing requirement specifications to vendor assessment, installation and operational qualification and ongoing testing during routine use. This interactive workshop will help attendees understand the instrument qualification and system validation processes and will provide templates and examples to develop...
WEBINAR
APR
10
10:00 AM
I-9 Compliance: Knowing What to Do and When to Do It
Online Event, Palo Alto, CA, USA
In compliance with the IRCA, all U.S. employers must verify the identity and employment eligibility of all new employees (both citizen and noncitizen) hired after November 6, 1986. This requirement is satisfied by having new employees and their employer complete Form I-9. This training program will discuss the immigration law, Form I-9 review and completion, and common I-9 mistakes. Why Should You Attend: The Immigration Reform and Control Act of 1986 (IRCA) imposes civil and criminal fines penalties for employment of illegal aliens. Individuals responsible for IRCA compliance can be held...
WEBINAR
APR
10
10:00 AM
Is it Method Verification or Validation, or Just Semantics?
Online Event, Palo Alto, CA, USA
The webinar will discuss the distinction between and requirements for method validation and method verification to comply with ISO/IEC Standard 17025:2005 for a microbiology laboratory accreditation. Why Should You Attend: Although method validation and method verification are related terms, they have very different analytical and statistical requirements particularly for compliance with ISO/IEC 17025:2005. In this session, attendees will learn: The difference between method validation and verification The performance characteristics for method validation Performance requirements for...
WEBINAR
APR
10
10:00 AM
Why Fraud Happens and What to do
Online Event, Palo Alto, CA, USA
Auditors and financial managers are not expected to have the expertise of forensic investigators, but they should have adequate knowledge of the aspects of fraud and maintain a skeptical mind when it comes to reviewing potential violations. Like internal controls, the economy, and business strategy, fraud continues to evolve and auditors must stay abreast of its root causes. This training program will highlight these root causes and detail suggested mitigation and investigation techniques. Why Should You Attend: Inherently, organizations strive to ensure the individuals they hire are honest...
WEBINAR
APR
10
10:00 AM
Private Placements and Red Flags to Look For
Online Event, Palo Alto, CA, USA
In today’s world of private placements and private equity offerings, it is of utmost importance to understand and evaluate what is being offered for sale. This means appropriate and meticulous due diligence on the offering is critical before making a purchase, or, for that matter, before offering the investment to the public. This webinar will help teach accredited investors as well as financial intermediaries what to look for when reading an offering memorandum. It is important to question anything and everything that seems unusual or doesn’t pass the smell test and not ignore these red...
WEBINAR
APR
10
10:00 AM
Electronic Records and Signatures - 21 CFR Part 11: Basic Concepts
Online Event, Palo Alto, CA, USA
This webinar will introduce attendees to key components of a computerized system validation master plan and set out the requirements for compliance as per FDA’s 21 CFR 11. It will detail several aspects such as requirements, design, configuration specifications, validation testing, procedures/archival/traceability, and best practices for system decommissioning/retirement as well. Why Should You Attend: The comprehensive testing and control of computerized systems is first and foremost a matter of business continuity. The industry is absolutely dependent upon the reliability and accuracy...
WEBINAR
APR
09
10:00 AM
Export Audit Compliance Focused Assessment
Online Event, Palo Alto, CA, USA
This training program will address the export audit compliance procedures that will emphasize the appropriate documentation often used in the country market system and its product competitiveness research methods for conducting trade transactions. It will focus on identifying customers, such as the end users, distributors, and sales agents and examine the compliance procedures within foreign law justification. Finally, the webinar will address the sales documentation and other record-keeping compliance procedures that should be used by the exporter when dealing with customs for particular...
WEBINAR
APR
09
10:00 AM
Getting to Know FDA Audit Practices
Online Event, Palo Alto, CA, USA
Learn more about FDA’s current audit techniques and the most commonly cited GMP deficiencies that you have to watch out for. The webinar instructor, an FDA and GMP training expert, will help attendees analyze a system of risk assessments to determine audit frequencies. Why Should You Attend: The success of an audit by federal regulators does not always depend on the level of training proffered to staff and department employees, but also in understanding the focus of recent inspections within the industry. Such information provides a template for companies to analyze their own practices...
WEBINAR
APR
09
10:00 AM
Writing and Implementing Statistical Analysis Plans
Online Event, Palo Alto, CA, USA
This training on clinical trial Statistical Analysis Plans (SAP) will review writing, timing and specific content of the SAP in the context of FDA guidance based on ICH E9 with references to ICH E3 and E6. We will work through a sample template and discuss how to approach each section for maximum clarity and ease of interpretation at the end of a study. Why Should You Attend: The statistical analysis plan (SAP) is a key component of a clinical trial. It is a prospective plan of statistical methods not detailed in the Protocol. While the protocol is primarily concerned with design...
WEBINAR
APR
09
10:00 AM
OSHA Enforcement: Meeting the OSHA Initiative on Temporary Workers
Online Event, Palo Alto, CA, USA
With OSHA’s new initiative to ensure the health and safety of temporary workers program, procedural changes to your operations may be required. This course will provide the necessary decision making and determination as to what will be required. Why Should You Attend: This course will offer an insight into the potential relationship between the employer and the employee as it relates to safety and health issues. You need to understand your responsibilities for temporary employees at your site as it relates to training, PPE, and OSHA recordability for injuries/illnesses. This training...
WEBINAR
APR
08
10:00 AM
The Sunshine Act Reporting for Clinical Trials
Online Event, Palo Alto, CA, USA
This webinar will discuss the disclosure requirements for clinical investigators under the Sunshine Act. It will discuss the details of the processes; provide templates for reporting formats; and timelines for reporting. Why Should You Attend: The Sunshine Act exposes the physicians and sponsors to new reporting requirements which are unprecedented in their scope and detail noncompliance to which would lead to hefty fines. This webinar will summarize the new requirements and provide practical solutions to most common situations that are prevalent and necessary between sponsors and...
WEBINAR
APR
08
10:00 AM
FDA's Ambitious Regulation of Social Media
Online Event, Palo Alto, CA, USA
FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk...
WEBINAR
APR
08
10:00 AM
W-2s vs. 1099s - Who Should Be an Independent Contractor?
Online Event, Palo Alto, CA, USA
This course will enhance participants' understanding of an employer's responsibilities in hiring independent contractors. It will further distinguish between an independent contractor and a temporary employee, laying emphasis on the parameters detailed in Form W-2 and Form 1099-S. It will include discussions on the Department of Labor's view and the EEOC’s involvement as well. Why Should You Attend: It started out seeming like a good idea at first: cutting overhead and payroll costs by maximizing the use of independent contractors. Having a flexible workforce that you don't have to pay...
WEBINAR
APR
08
10:00 AM
Evaluating the Effectiveness of your ERM Program
Online Event, Palo Alto, CA, USA
This webinar will detail ERM core elements and discuss the basics of risk assessment. Attendees will learn to identify critical risk areas and mange backlog of risk areas as well. Why Should You Attend: Versions of enterprise risk management, risk management, contingency planning, etc. have been implemented and used with varying levels of success by leaders globally. One of several ways to extract more value from existing regulatory focused processes and procedures is to learn where to improve strategically and operationally. Far too many leaders view risk management processes as merely...
WEBINAR
APR
08
10:00 AM
Combination Drug/Device Products CGMPs - Final Rule
Online Event, Palo Alto, CA, USA
This training on combination product regulations will evaluate the chief areas of concern or change in the new CGMP requirements for combination products, 21 CFR Part 4, and clarify many of the issues and questions that arise involving combination products. Why Should You Attend: There has been much past confusion on the production and handling of drug / device (and/or biologics) combination products. Companies involved in the production of such products have pieced together what they've considered the applicable elements of the pharma and device CGMPs, 21 CFR 210/211 and 820; sometimes...
WEBINAR
APR
07
10:00 AM
Investigating Internal Non Compliance Complaints for the General Counsel
Online Event, Palo Alto, CA, USA
This webinar will help general counsel and senior HR executives work together to better understand internal complaint systems, and design, establish, and maintain an effective system for handling employee complaints in the workplace when associates charge that the employer has violated one or more of the laws that regulate the employer-employee relationship. The course will review three examples in this session - FSLA, FMLA, and USERRA. Why Should You Attend: This webinar is for general counsel who manage the work output and the results of decision making by HR executives and key managers...
WEBINAR
APR
07
10:00 AM
Troubleshooting Ethylene Oxide (EO) Processes
Online Event, Palo Alto, CA, USA
This EO sterilization training Webinar will discuss the important parameters to measure for the sterility assurance level and actions to take if they are not compliant to the process specification. Why Should You Attend: Ethylene oxide (EO) sterilization is the most complicated of the industrial sterilization methods. It is not uncommon for anomalies to occur during qualification or routine processing. These anomalies may come in the form of sterilization cycle parameter that is not achieved or a positive biological indicator. Not knowing how to respond to these situations can result in a...
WEBINAR
APR
07
10:00 AM
Affordable Care Act New Tax Penalties: Impact on Individuals and Employers
Online Event, Palo Alto, CA, USA
This webinar will instruct participants on the new penalties issued to individuals and employers who lack coverage altogether or whose healthcare coverage fails to meet Affordable Care Act (ACA) standards. Attendees will also learn how to compute the required annual payment, i.e., the shared responsibility payment. This two-hour webinar will focus on requirements set forth for individuals and employers filing the new form 1095-C. Why Should You Attend: The penalty on individuals who lack coverage altogether or whose coverage fails to meet ACA standards will kick in with the 2014 filing...
SEMINAR
APR
02
8:30 AM
Auditing and Administrating Human Resource Policies and Practices: 2-Day In-Person Seminar
, New York, NY, USA
Course Description: Human resource administration is complex today. Much information must be gathered and kept for each employee and human resource departments must know what is required, how to handle the information, how to protect the privacy and rights of its employees, how to follow proper record-keeping procedures and how to assure policies are up-to-date, viable, understood and followed by management and employees. The execution of these policies and practices is equally important to establishing them. Beginning with an overall audit of human resources practices, this seminar covers...
WEBINAR
APR
01
10:00 AM
Developing an Infection Control Plan: Risk Assessment
Online Event, Palo Alto, CA, USA
The primary focus of infection control and prevention programs is to prevent and control hospital-associated infections in patients, staff and visitors. This training session will highlight the critical components of an infection control plan and identify specific benchmarks for the HAI (healthcare associated infections) surveillance. Why Should You Attend: The infection control plan is the foundation to an effective infection prevention and control program in a facility. In this webinar, attendees will learn the steps to writing or revising an existing infection control plan. It will...
WEBINAR
APR
01
10:00 AM
Constructing an Effective Argument
Online Event, Palo Alto, CA, USA
The ability to construct and present a winning argument by those without direct control over business processes or organizations is the key requirement to excel in today’s risk and auditing environment. This webinar will provide participants with tools and strategies that will improve the quality of your argument thereby improving your chances for providing positive, substantial and effective advice. Why Should You Attend: Conquest: Any argument is successful when the end result is planned and visualized. Participants will understand techniques for recognizing potential results early in...
WEBINAR
APR
01
10:00 AM
Intersection of AML-OFAC Requirements with FATCA Requirements
Online Event, Palo Alto, CA, USA
This session will explore the different requirements of FATCA, AML, OFAC and how to avoid breaking these regulatory requirements. You will understand how to deal with all the differing requirements and developing a Customer Due Diligence strategy to deal with such scenarios. Why Should You Attend: FinCen’s proposed rule on beneficial ownership (“Customer Due Diligence Requirements for Financial Institutions”) and the EU’s Fourth Anti-Money Laundering Directive both set the threshold for identifying an entity’s individual beneficial owners at 25% (or otherwise exercises control)....
SEMINAR
MAR
30
8:30 AM
Anti-Corruption Compliance - Understanding the OECD Anti-Bribery Convention
, Perth WA, Australia
Course Description: Bribery can often damage your business and your reputation. However, your business is not the only victim. The government and the society are affected more, and they are severely undermined by the weakened rule of law and damaged economic and social development. As such, governments are making anti-corruption programs an integral part of compliance. The OECD and its member countries see the core principle in fighting corruption rooted in the principle of free and fair competition. Each bribe offered or accepted compromises this principle. This two-day training course is...
WEBINAR
MAR
28
10:00 AM
Product Standards, Menthol and FDA's Deeming Regulation
Online Event, Palo Alto, CA, USA
This training session will instruct attendees on the Tobacco Control Act’s Section 907 Product Standards, the status of menthol as a characterizing flavor, as well as FDA’s Deeming Regulation, which proposes to give FDA authority over currently unregulated tobacco products such as electronic cigarettes, cigars and pipe tobacco. Why Should You Attend: The Tobacco Control Act has changed the way the tobacco industry operates in the United States. One of its key features is the ability to establish product standards for regulated products. This webinar will examine the product standards...
WEBINAR
MAR
27
10:00 AM
How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation
Online Event, Palo Alto, CA, USA
This training program will discuss designing an effective cleanroom facility validation protocol and report, when and how to transition into the routine environmental monitoring processes, how to maintain a state of control within the cleanroom, and the routine environmental monitoring and excursion investigation processes. Why Should You Attend: This 90-minute training will provide participants an understanding of: The regulations guiding cleanroom facilities What constitutes an effective design Cleanroom classification How a cleanroom validation should be structured Routine...
WEBINAR
MAR
27
10:00 AM
The Saving Grace of Internal HR Audits
Online Event, Palo Alto, CA, USA
This training session will define why HR audits are a vital part of a comprehensive strategy to help avoid those areas of concern that may need immediate attention. It will discuss key HR areas to audit and list six quick steps to a perfect audit. Why Should You Attend: How is your HR department doing? Noncompliance problems can be, and frequently are, the basis for significant financial risk. Can you answer these questions: Would your company pass an I-9 audit? Do you provide the correct COBRA information at the right time? Do you understand records retention requirements for the...
WEBINAR
MAR
27
10:00 AM
How to Manage an Effective AML Audit Program
Online Event, Palo Alto, CA, USA
This webinar will highlight the techniques and best practices that can be used for conducting an effective AML audit in order to ensure compliance with Bank Secrecy Act (BSA) regulations. Why Should You Attend: Financial institutions are continually evolving their systems and processes, and some continue to be challenged by risks associated with conducting an inadequate audit. Recent actions have brought forth regulatory criticisms for inadequate scoping and testing of audits. With more scrutiny placed on internal audit to have deep expertise in BSA/AML, many financial institutions are...
WEBINAR
MAR
27
10:00 AM
The Saving Grace of Internal HR Audits
Online Event, Palo Alto, CA, USA
This training session will define why HR audits are a vital part of a comprehensive strategy to help avoid those areas of concern that may need immediate attention. It will discuss key HR areas to audit and list six quick steps to a perfect audit. Why Should You Attend: How is your HR department doing? Noncompliance problems can be, and frequently are, the basis for significant financial risk. Can you answer these questions: Would your company pass an I-9 audit? Do you provide the correct COBRA information at the right time? Do you understand records retention requirements for the...
WEBINAR
MAR
27
10:00 AM
How to Manage an Effective AML Audit Program
Online Event, Palo Alto, CA, USA
This webinar will highlight the techniques and best practices that can be used for conducting an effective AML audit in order to ensure compliance with Bank Secrecy Act (BSA) regulations. Why Should You Attend: Financial institutions are continually evolving their systems and processes, and some continue to be challenged by risks associated with conducting an inadequate audit. Recent actions have brought forth regulatory criticisms for inadequate scoping and testing of audits. With more scrutiny placed on internal audit to have deep expertise in BSA/AML, many financial institutions are...
WEBINAR
MAR
26
12:00 PM
Maintaining Continuous HIPAA Compliance through Effective Monitoring and Auditing Practices
Online Event, Palo Alto, CA, USA
This webinar will explain how to design and administer monitoring and auditing programs to ensure compliance with HIPAA regulations to avoid penalties. It will discuss some of the most common exceptions under the HIPAA Privacy Rule. Why Should You Attend: HIPAA ‘covered entities’ (providers, health plans, and clearinghouses) and ‘business associates’ should implement and maintain sound monitoring and auditing practices. Those practices should help covered entities and business associates avoid or reduce the risk of civil or criminal sanctions for HIPAA violations. The new leadership...
WEBINAR
MAR
26
11:00 AM
Supply Chain and Product Compliance Using RoHS, REACH, and Conflict Minerals
Online Event, Palo Alto, CA, USA
This training program will offer an in-depth look at three important product regulations focused on materials compliance and ethical sourcing, along with the tools and policies needed to implement them. Why Should You Attend: The European Union and the United States are leading the world in product regulations focused on environmental compliance and ethical sourcing. Compliance is mandatory in order to continue manufacturing, shipping, and selling products in Europe and the U.S. It is required that companies comply with the use laws and limits for each material, along with documenting the...
WEBINAR
MAR
26
10:00 AM
Equipment Calibration, Maintenance, and Validation: What Auditors Look for in a Controlled Process
Online Event, Palo Alto, CA, USA
This webinar will discuss the different aspects which auditors generally look in equipment calibration, maintenance and validation and highlight the best practices. Why You Should Attend: FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include: intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements. Prior to use, however, this equipment must be validated to make sure it produces product...
WEBINAR
MAR
26
10:00 AM
Designing Effective and Efficient Extractables or Leachables Studies for Biologics
Online Event, Palo Alto, CA, USA
Understand the steps of a extractables / leachables study, get knowledge about the gap analysis of literature sources and how to design an efficient E/L study. Why Should You Attend: The FDA industry guidance for container-closure systems for packaging human drugs and biologics requires the testing of container closure components for extractable leachable for all injectibles. Since biologics products are particularly sensitive to leachable there has been increased scrutiny of extractable and leachable associated with biotechnology drug products. The time and resources required for testing...
WEBINAR
MAR
26
9:00 AM
Data Breaches: What's the Risk?
Online Event, Palo Alto, CA, USA
This webinar will discuss the risks and costs of data breaches. Participants will learn who is vulnerable and what can be done to help prevent losses from data breaches. Additionally, the course will discuss the legal responsibilities and liabilities of an organization that is a victim of data breach and offer guidance to help prevent such breaches. Why Should You Attend: Data breaches are a real risk for businesses. Instances of data breach are being reported widely and constantly. Computer hackers don’t just target big businesses; they go after small and medium sized businesses as...
SEMINAR
MAR
26
8:30 AM
FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials: 2-day In-person Seminar
, Tampa, FL, USA
Course Description: Manufacturing an investigational product for the initial pilot clinical trials could pose a considerable logistical and financial challenge to developers. The first-in-man and pilot clinical trials are usually conducted in very small number of healthy participants with lower doses primarily to establish safety and hence do not need a significant amount of investigational material. The US FDA allows developers to test early stage investigational products under relaxed GMP requirements. The manufacturing requirements for early stage clinical trials are designed to assure...
SEMINAR
MAR
26
8:30 AM
Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices
, San Francisco, CA, USA
Course Description: Federal regulation of the advertising and promotion of pharmaceuticals and medical devices reflects an aggressive attitude on the part of the regulators that demands, in turn, that industry be keenly aware of the legal and regulatory duties, as well as key recent trends in enforcement activities by the Federal Government. This course will explore in detail what FDA requires of drug and device firms as well as recent current hot buttons in FDA enforcement activity for the advertising arena. What’s at stake if your advertising and promotional efforts violate the law?...
SEMINAR
MAR
26
8:30 AM
Risk Based Internal Auditing (RBIA): 2-day Comprehensive Training Workshop
, Sydney NSW, Australia
Course Description: The Institute of Internal Auditors defines Risk Based Internal Auditing (RBIA) as a methodology that links internal auditing to an organization’s overall risk management framework. RBIA allows internal audit to provide assurance to the board that risk management processes are managing risks effectively, in relation to the risk appetite. But every organization is different. There are different attitudes to risk, different management and organizational structures, different processes and procedures, and the need to subscribe to and comply with different conventions and...
WEBINAR
MAR
25
10:00 AM
Creating Effective SOP for Regulatory Compliance
Online Event, Palo Alto, CA, USA
This FDA documentation webinar will explain the regulatory expectations for, and the proper design and maintenance of effective and compliant standard operating procedures (SOPs). Why Should You Attend: The lack of or inadequate standard operating procedures (SOPs) continue to dominate the FDA's inspectional observations. Their frequency lags only behind the quality unit concerns. Moreover, SOPs are often used as training tools, which means that they need to be easily understood by all those whom they affect. Effective SOPs are not only a regulatory requirement; they also make good business...
WEBINAR
MAR
25
10:00 AM
Accounts Payable Fraud - Detecting and Preventing AP Fraud
Online Event, Palo Alto, CA, USA
This 90-minute webinar will guide you through the critical steps in ensuring strong controls for the accounts payable (AP) function and provide practical 'how to' guidance for minimizing your organization’s exposure to AP fraudsters. Why Should You Attend: According to the Association of Certified Fraud Examiners, businesses suffer an average of $155,000 every time an insider commits fraud. More disturbing: Billing schemes are by far the most common fraud schemes threatening organizations, making up nearly one-third of the total. Adding to the problem, check fraud is rising at a rate of...
WEBINAR
MAR
24
10:00 AM
ICH Q10 - Moving From GMPs To A Pharmaceutical Quality System
Online Event, Palo Alto, CA, USA
This ICH Q10 training /webinar will discuss the evolution and interpretation of the pharmaceutical GMPs as a quality control regulation to the Quality Assurance emphasis of the Pharmaceutical Quality System as defined in ICH Q10. Why Should You Attend: Since the release of the Quality System Regulation for medical devices, the FDA has been trying to transition the pharmaceutical industry to a Quality System approach to compliance. The issuance of the Guidance for the Industry: Quality System Approach to Pharmaceutical CGMPS and ICH Q10. Pharmaceutical Quality System has brought new focus to...
WEBINAR
MAR
24
10:00 AM
Cash Flow Analysis: Effective Cash Flow Management
Online Event, Palo Alto Square, Palo Alto, CA 94306, USA
Determining the ability of an entity to generate cash flow is essential whenever the repayment of a loan will extend beyond one year. Cash flow analysis measures the ability of an entity to generate sufficient cash to operate the business successfully and have excess cash to serve the annual debt payment requirements. Understanding how to calculate and interpret cash flow is essential for successful banking. This training session will offer participants a good understanding of how cash flow is calculated, and more importantly, how to interpret its meaning. Why Should You Attend: This course...
SEMINAR
MAR
23
8:30 AM
How to Successfully Manage an FDA High Risk Food Inspection
, Orlando, FL, USA
Course Description: This course will present an overview of necessary actions that companies should take to be audit-ready, such as: Performing a hazard analysis Developing and implementing an adequate HACCP plan or food safety plan (under FSMA) Performing end-product and /or environmental sampling Auditing suppliers of high risk food ingredients and/or sample testing incoming ingredients It will identify what high risk foods are in relation to food safety and highlight current FDA regulations that regulate the processing and packing of high risk foods. It will provide valuable...
SEMINAR
MAR
23
8:30 AM
Operations Risk Management and Mitigation - from Assessment to Implementation
, Sydney NSW, Australia
Aims This is an intensive course on Operational Risk Management & Mitigation – from assessing the operational risks to how to implementing a working, viable operational risk management system. Aimed at the financial services industry this course explores the Operational Risk Management (ORM) function and mitigation requirements as mandated in the Basel Accords. A key objective of this course is to move the participants beyond the operational risk compliance requirements set down in the Basel Accords to an understanding of managing operational risk as a value added proposition that can be...
WEBINAR
MAR
20
10:00 AM
Superiority, Non-inferiority, or Equivalence Trials: How, Why and When
Online Event, Palo Alto Square, Palo Alto, CA 94306, USA
This webinar on clinical study design will explore the differences among superiority, Non-inferiority (NI), and equivalence trials, including development of the precise research questions necessary to making a decision about appropriate clinical designs. Why Should You Attend: Randomized Control Trials (RCT) aimed at showing superiority remain the gold standard in clinical trial research, but are not appropriate for trials in which the aim is to show that a new treatment is equivalent or at least non-inferior to the current standard of care. The design of NI and equivalence trials is not as...
WEBINAR
MAR
19
10:00 AM
Report Writing for Auditing Professionals
Online Event, Palo Alto Square, Palo Alto, CA 94306, USA
Skilled auditors require a method that aligns what they experienced during the reviewing process with what they compose during the writing process. This report writing workshop will provide foundation resources that participants can continually turn to during intense, complex audit engagements. Why Should You Attend: The art of audit report writing demands far more than simply listing the four elements of a finding–criteria, condition, cause, and effect. Adding the fifth element, the recommendation, may still be insufficient. This boilerplate approach to writing can threaten independent,...
WEBINAR
MAR
19
10:00 AM
Establishing Effective Enterprise Risk Management
Online Event, Palo Alto Square, Palo Alto, CA 94306, USA
Enterprise risk management has become the new buzz word for business. This webinar training will highlight best practices for members of the board of directors and senior management for implementing and maintaining an enterprise risk management program. It will provide advice on what regulators look for in proper governance procedures and documents. The session will follow the creation of a risk management program and explain how the program should be managed by the company’s board. Why Should You Attend: Regulatory agencies are taking a harder look at business operations. Compliance has...
WEBINAR
MAR
19
10:00 AM
Current Concepts and Challenges in Cloud Compliance
Online Event, Palo Alto Square, Palo Alto, CA 94306, USA
Cloud computing has become perhaps the most critical compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantee that management will expect compliance strategies to be developed that will support decisions to utilize cloud environments to perform regulated activities. This presentation will provide a baseline of information related to cloud computing which will help attendees better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when...
WEBINAR
MAR
19
10:00 AM
Excel Spreadsheets: Develop and Validate for 21 CFR Part 11 Compliance
Online Event, Palo Alto Square, Palo Alto, CA 94306, USA
Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time. Why Should You Attend: This course will train attendees on best practices to create a spreadsheet that is GxP compliant using Microsoft Excel. Attendees will understand how to validate applications with minimal documentation. The course will also offer step-by-step instructions to configure Excel for audit trails, security features, and data entry verification. This session will also include an interactive workshop for participants to learn important...
WEBINAR
MAR
19
10:00 AM
The Respectful Workplace: Harassment Prevention & Intervention for Managers
Online Event, Palo Alto Square, Palo Alto, CA 94306, USA
Learn as a manager, how to detect harassment early and manage proactively. Why Should You Attend: Speak ill of no one, but speak all the good you know of everybody. Are you concerned about keeping an harassment-free workplace? Are your managers confused about what is and isn’t appropriate for their employees to say and do? Do you have a policy in place that no one read or knows how to follow? Judi Clements can help. This program is designed to help managers and supervisors take the guess work out of workplace harassment. They’ll hear about case studies that will sharpen their skills...
SEMINAR
MAR
19
8:30 AM
Lifecycle Approach to Analytical Methods for Drug Products
, Washington, DC, USA
Course Description: This highly interactive course is designed to provide participants with a lifecycle approach to developing and validating analytical methods, including elements aligned with QbD concepts. Some of the key aspects of the seminar include: Learning how to apply QbD concepts to analytical methods Discussing the types of methods required for different drug products Understanding the types of impurities which must be addressed for drug products Discovering how a lifecycle approach can link method development, validation, verification and transfer Learning how ATP...
WEBINAR
MAR
18
10:00 AM
Project Management for FDA-Regulated Companies
Online Event, Palo Alto Square, Palo Alto, CA 94306, USA
This project management training for FDA regulated companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for successful development and implementation of project management planning. Why Should You Attend: The FDA expects companies to manage projects formally, with a written plan -- to include regulatory requirements, design and/or change control, with consideration of all applicable standards, and to demonstrate "progress against plan". The EU MDD and their notified bodies are no...
WEBINAR
MAR
17
10:00 AM
Understanding FMLA and ADA
Online Event, Palo Alto Square, Palo Alto, CA 94306, USA
This webinar will cover both Family and Medical leave Act (FMLA) and the Americans with Disabilities Act (ADA) federal regulations. It will help attendees understand their responsibilities and rights under these federal laws. Why Should You Attend: Family and Medical leave Act (FMLA) and the Americans with Disabilities Act (ADA) administration are growing concerns for employers. The regulations regarding FMLA and ADA can be very confusing for employers. This webinar will explain the basics of both FMLA and ADA federal regulations. Attendees will learn how to best manage these...
WEBINAR
MAR
17
10:00 AM
Introduction to International Letters of Credit
Online Event, Palo Alto Square, Palo Alto, CA 94306, USA
Attend this webinar to understand the process of a letter of credit and how to comply with letter of credit requirements to help reduce or prevent costly discrepancies. Why Should You Attend: A letter of credit is one method of payment used in international trade transactions. The Uniform Customs and Practices (UCP 600) are the current internationally recognized set of rules created by the International Chamber of Commerce (ICC) which govern the use of letters of credit. The benefit to using a letter of credit is that it provides a conditional guarantee of payment from the importer...
WEBINAR
MAR
17
8:00 AM
BSA and Privately Owned ATMs Risk
Online Event, Palo Alto Square, Palo Alto, CA 94306, USA
This training on Bank Secrecy Act regulations will highlight BSA compliance and its applicability to privately owned ATMs. It will look at the privately owned ATMs areas and the specifics of each area as it pertains to BSA compliance. Why Should You Attend: Although financial institutions have been managing BSA operations per the regulation requirements, the change in focus to privately owned ATMs has become increasingly important. Regulators look to the bank for insurance and evidence that BSA operations are being appropriately applied to privately owned ATMs. This webinar will highlight...
WEBINAR
MAR
16
10:00 AM
Wage and Hour Law - California Style
Online Event, Palo Alto Square, Palo Alto, CA 94306, USA
This 90 minute California wage and hour compliance training will help you understand the complexities surrounding California wage and hour laws and how it affects the function of any payroll department or company that has employees in California. Why Should You Attend: It has been said that California has a style all its own. This is especially true in the area of employment law. With arguably the greatest amount of wage and hour laws on the books of any state, processing payroll and keeping in compliance with California requirements can be a complex situation. Issues involving overtime,...
WEBINAR
MAR
13
10:00 AM
How to Successfully Manage an FDA High Risk Inspection
Online Event, Palo Alto Square, Palo Alto, CA 94306, USA
This training session on managing an FDA high-risk food inspection will outline proactive measures that food processors can take to successfully manage and pass a high risk FDA inspection. It will emphasize the need to be audit ready at all times, and not just when you suspect that your company will be audited. Why Should You Attend: This webinar will train participants in complying with FDA high risk food regulations, particularly high risk foods that will be regulated under FDA’s proposed new preventative controls regulation – 21CFR Part 117 and existing regulations – Low Acid...
WEBINAR
MAR
13
10:00 AM
You have a BI Positive or Product Sterility Positive - Now What?
Online Event, Palo Alto Square, Palo Alto, CA 94306, USA
This webinar will discuss what actions should be taken following a positive result in a sterility test on a biological indicator (BI) during performance qualification or routine testing. It will also explain the various items that should be investigated to determine the root cause and the follow up to the investigation. Why Should You Attend: All sterile products require some level of sterility and bioburden testing during validation and then during routine production. What actions your company takes when this testing exhibits results that do not meet specifications can be critical from a...
WEBINAR
MAR
12
10:00 AM
Form W-2 for 2015: All You Need to Know
Online Event, Palo Alto Square, Palo Alto, CA 94306, USA
Form W-2 is one of the most important documents that payroll departments must process. To prove that the form is correct, payroll must reconcile this form to itself, the payroll and all of the Forms 941 submitted in 2015 or face fines by the IRS, the SSA or both. This webinar will discuss the 2015 Form W-2 and the IRS’ requirements for completing, processing, submitting and correcting the form. Why Should You Attend: Each year the Form W-2 is reissued by the IRS and 2015 is no exception. So what is new for this year and what changes are in place for upcoming years? Do I reissue...
WEBINAR
MAR
12
10:00 AM
Your HIPAA Compliance Plan and Cloud Storage Security
Online Event, Palo Alto Square, Palo Alto, CA 94306, USA
This course will help you understand how to insulate your company from legal liability by association when breaches occur with cloud based BAs. The webinar is designed to share metrics that will protect your company from OCR scrutiny, should your cloud provider encounter a breach. These tools will help you understand your responsibility with business associates and how to ensure that your company's credibility is not damaged when a breach occurs beyond your control. Why Should You Attend: Most people are overwhelmed by HIPAA/HITECH Act requirements, required to ensure company-wide...
WEBINAR
MAR
12
10:00 AM
Selection and Use of Reference Material in Analytical Laboratories
Online Event, Palo Alto Square, Palo Alto, CA 94306, USA
This training on using certified reference material in analytical laboratories will cover FDA and international requirements for selection, purchasing, testing, storage and use of (certified) reference material. Why Should You Attend: Most important for getting correct analytical results is the use of accurate standards or (certified) reference materials. No matter how skilled the analysts are or how sophisticated and automated the equipment, if the calibration of the system is incorrect, the analytical result will always be wrong. Because of this FDA inspectors expect companies to have...
WEBINAR
MAR
12
10:00 AM
Guidelines for Performing Fraud Risk Assessment
Online Event, Palo Alto Square, Palo Alto, CA 94306, USA
This webinar will explain key components of a fraud risk assessment and management program. Attendees will learn best practices for conducting an internal fraud investigation. Why Should You Attend: With an increased awareness of fraud and the ongoing cost to organizations, an entity wide fraud risk assessment is imperative to all organizations. Performing a fraud risk assessment is doable, and can provide internal audit and its organization peace of mind for having gone through the process. Once it is completed, it only requires an annual review for additions of possible new fraud schemes...
SEMINAR
MAR
12
8:30 AM
APT Audit Process – How Agile is Your Audit Process? Risk Based Auditing 2020
, New York, NY, USA
Course Description: Increasing demands on the audit profession by regulators, industry watchdogs and the IIA itself begs for new approaches and enhanced risk perspectives. BASEL requirements and COSO directives support even more risk based auditing activity while senior management expects auditors to not only understand risk and controls but to actively contribute in that same space as other risk experts. This course will introduce participants to the first agile risk based audit approach available. Agility plus 10.1 (APT) is designed to ensure that while adhering to the standards of the...
SEMINAR
MAR
12
8:30 AM
California Laws Regulating Employment Screening and Safe Hiring: 2-Day In-Person Seminar
, San Francisco, CA, USA
Course Description: It’s never been more challenging to find and hire the right people. Employers are concerned not only about getting the right ‘fit,’ but also about legal regulations, discrimination, privacy concerns and limited budgets. Without exercising due diligence in hiring, employers also risk mistakes that can result in legal and financial nightmares including workplace violence, unqualified employees, theft and litigation for negligent hiring. On the other hand, failure to follow legally complaint hiring practices can result in regulatory actions and class action...
SEMINAR
MAR
12
8:30 AM
Trade Compliance Seminar - Harmonized Tariff Schedule/Schedule B
,
Course Description: Gain in-depth knowledge on Harmonized Tariff Schedules and get up-to-date with NAFTA rules of origin and documentation. In addition, get complimentary copies of reference books related to each topic. Day 1 - Harmonized Tariff Schedule and Schedule B , Thursday, March 12, 2015, 8:30 AM to 4.45 PM, Anaheim, CA The day one of seminar will help to better understand, through simple examples and workshops, the rules that are required to classify products in the Harmonized Tariff Schedule (HTS) or Schedule B. Importers or exporters can be subject to severe penalties if they...
WEBINAR
MAR
10
11:00 AM
Developing an Operational Risk Appetite Statement
Online Event, Palo Alto Square, Palo Alto, CA 94306, USA
This webinar will discuss the challenges and opportunities involved in developing and implementing an operational risk appetite statement, which is supported by operational risk limits, and the determination of actual exposure against those limits. Why Should You Attend: Regulators, credit rating agencies, board members, shareholders and other stakeholders expect that financial services companies clearly articulate and quantify their appetite for each type of risk taken by the company in pursuit of its objectives. While significant progress has been made since the financial crisis to...
WEBINAR
MAR
10
10:00 AM
Good Laboratory Practices for Food Manufacturing
Online Event, Palo Alto Square, Palo Alto, CA 94306, USA
Food manufacturers and food processors are constantly collecting data for quality analysis. This data collection process often needs to be analyzed. GLPs are used for data collection and data quality. It is not to be confused with laboratory safety (such as PPE). This training session will focus on fundamental areas of focus of GLP, the history of GLP principles, and the importance of compliance with GLP regulations. Why Should You Attend: This session is designed for manufacturers interested in learning more about the fundamentals of good lab practices for food manufacturing. Regulatory...
SEMINAR
MAR
10
8:30 AM
Manufacturing and Marketing Cosmeceutical* and Homeopathic OTCs
, San Diego, CA, USA
Course Description: This interactive one and a half day seminar is intended to help companies understand the legal definitions of cosmetics, drugs, dietary supplements and why products of similar composition may be defined differently by their labeling and thus have to meet different regulatory requirements. It will also explain differences in the way homeopathic and conventional drugs are regulated. It will address such issues as: How the intended use of the product owner defines a product Can a drug contain both allopathic and homeopathic ingredients Information that must appear on...
SEMINAR
MAR
09
8:30 AM
Application of Disinfectants and Sterilants to Control Microorganisms; FDA Endotoxin Test
, San Francisco, CA, USA
Course Description: Microbiology plays a role throughout the manufacture of pharmaceutical products. Both non-sterile and sterile products are susceptible to the microorganisms they contact during the manufacturing process which may include raw materials, in-process operations and the final product. The environmental and utility systems must also be maintained as must the packaging components, manufacturing equipment, and personnel. To maintain this controlled process and environment, sanitizers, disinfectants and sterilants (sporicides) are essential. Maintaining this controlled...
SEMINAR
MAR
09
8:30 AM
Business Continuity and Scenario Planning: 2-day In-person Seminar
, Boston, MA, USA
Aims: A 2-day intensive course on business continuity and scenario planning focused on the banking/ financial institution environment with a view to provide banking professionals with a firm foundation of the standards of best practices in the critical area of business continuity planning. The Basel Accords have raised the profile of operational risk. There are a range of challenges within the accords where financial service firms need to consider a wide range of complex issues including events that have not happened yet. One of the most crucial objectives of management is to learn how to...
WEBINAR
MAR
06
10:00 AM
OSHA Inspections - Avoiding the 10 Most Common Mistakes
OnlineEvent, Palo Alto Square, Palo Alto, CA 94306, USA
This OSHA inspection webinar will cover aspects of an OSHA inspection from how establishments are targeted, how to limit the scope of an inspection or investigation, how not to self-incriminate, and when and how to appeal. Why Should You Attend: An OSHA inspection can be a costly and disruptive experience for any employer, especially if that employer has not dealt with the Agency, does not have an in-house safety professional or attorney. An OSHA inspection that goes badly essentially says the employer has a defective safety program, is not sufficiently focused on the safety and health of...
WEBINAR
MAR
06
9:00 AM
Character of Reputation Risk: Risk or Just an Impact?
Online Event, Palo Alto Square, Palo Alto, CA 94306, USA
Reputational risk is receiving a tremendous amount of focus. Organizations need to have the capability to identify, manage and measure their reputational risk, while employees in every level are familiar with an effective approach towards the same. This training program will discuss how different companies have either failed or succeeded in managing their reputational risk and analyze best practices to take control of reputational risk situations. Why Should You Attend: Reputational risk affects every company: incidents will always happen even at the best-run companies. This webinar will...
WEBINAR
MAR
05
10:00 AM
The Changing Landscape and the Effect on the Conduct of Clinical Research
Online Event, Palo Alto Square, Palo Alto, CA 94306, USA
This clinical research training will explain the Institutional Review Board (IRB) models. It will discuss the regulatory framework for IRB review including 21 CFR 50, 56 and 45 CFR 46. Why Should You Attend: The number of clinical trials continues to increase. Clinical trials are no longer solely conducted at academic research centers or hospitals. Stand-alone facilities set up to conduct research are being established. Partnerships are being formed between traditional centers and the community. Multi-site studies are becoming the standard. Yet the regulations have not changed and IRBs must...
WEBINAR
MAR
05
10:00 AM
HR 101 for Non-HR Leaders
Online Event, Palo Alto Square, Palo Alto, CA 94306, USA
This webinar will detail key HR concepts and discuss best practices for recruitment, compensation and performance appraisals. Attendees from a non-HR background will find this course an excellent introduction to HR concepts and processes. Why Should You Attend: Human resource compliance has become increasingly complex in recent years. This presentation will provide basic information that will help managers in all areas identify potential HR 'hot buttons.' Every manager within an organization needs to have a basic understanding of HR laws and processes in order to deal with employee issues...
WEBINAR
MAR
05
10:00 AM
Writing Effective Audit Observations
Online Event, Palo Alto Square, Palo Alto, CA 94306, USA
This webinar will provide the principles for writing an effective audit report. The audit report represents the end result of weeks of reviews, analyses, interviews and discussions. It is used to provide information to management on the areas you reviewed. And, more importantly, the report brings issues to their attention that needs to be addressed. How well you communicate that information is critical to getting the results you are seeking. Why Should You Attend: An audit report typically represents the conclusion of weeks of reviews, analyses, interviews and discussions. It demonstrates...
SEMINAR
MAR
05
8:30 AM
Deconstructing Warning Letters - Using Warning Letters to Illustrate the FDA and Health Canada CFRs
, San Francisco, CA, USA
Course Description: Warning Letters continue to occur at a frequency that mirrors previous years. However, one of the major differences is that many of them are now originating in India, the second largest supplier of Active Pharmaceutical Ingredients (API) and finished drug products. The FDA, having recognized this, has now increased their staff to three offices and nineteen investigators across the country. As a result of this enhanced presence, more Warning Letters are arising from India and they provide excellent examples of issues that everyone should heed. The observations provide...
SEMINAR
MAR
05
8:30 AM
Individual Tax Minimization Strategies for 2015: 2-day In-person Seminar
, Las Vegas, NV, USA
Course Description: Did you know? Those taxpayers with incomes of $200,000 or more may be considered “high-income” taxpayers? That the income thresholds included in the Affordable Care Act are NOT indexed for inflation, meaning that more individuals will become subject to these taxes over time? If you were not aware of any of these facts, then attending this seminar would definitely be beneficial for you. This seminar will equip participants with viable tax minimization strategies that can be put to work immediately to reduce the tax burden of high income...
WEBINAR
MAR
04
10:00 AM
Meeting and Exceeding the Standards for Teen Workers in the Workplace
Online Event, Palo Alto Ave, Palo Alto, CA, USA
This course will offer guidance for those employing young personnel in their workforce. It will detail the standards applicable to them, provide resources for teens, parents, teachers, and employers, and illustrate workplace hazards that teen workers face. Why Should You Attend: It was reported that 4,628 workers died on the job in 2012. 19 of those deaths were under 16 years of age. 10 deaths were between 16 and 17 years old, and another 59 deaths were between 18 and 19 years old. It is estimated that every 9 minutes a teen is injured in the United States while on the job. As a teen...
WEBINAR
MAR
04
10:00 AM
Monitoring Impurities in Pharmaceutical Products - ICH Q3 requirements
Online Event, Palo Alto Square, Palo Alto, CA 94306, USA
This training will discuss regulatory requirements for monitoring of pharmaceutical impurities. It will explain how to monitor impurities in pharmaceutical products as per ICH Q3 A/B requirements and to measure the thresholds to report for regulatory submission. Why Should You Attend: Monitoring impurities is considered a critical activity of analytical development in order to ensure the quality of the pharmaceutical products. Current ICH Guidelines indicate that the measurement of impurities should always be conducted for active pharmaceutical ingredient (API) and its drug products. This...
WEBINAR
MAR
04
10:00 AM
How to Avoid an FDA Warning Letter with a Strong CAPA Program
Online Event, Palo Alto, Ojai, CA 93023, USA
This CAPA program provides the framework for avoiding an FDA warning letter and increasing quality standards for your organization while keeping production levels high. Description This course is appropriate for professionals who work within and manage a quality discipline for their organization. A strong and manageable CAPA program is critical in an FDA regulated environment. Over 50 warning letters have been issued to manufacturers in the medical device industry because of inadequate quality system procedures. This CAPA program provides the framework for avoiding an FDA warning letter...
WEBINAR
MAR
03
10:00 AM
10-Step Risk Based Computer System Validation for SaaS/Cloud/Local Hosting
Online Event, Palo Alto Square, Palo Alto, CA 94306, USA
Understand the 10-step risk based approach to validation, explore methods to decrease resource requirements, and learn how to make documentation more manageable and understandable. Why Should You Attend: This webinar will explore proven techniques that reduce validation project time, often to one-third. Attendees will learn efficient documentation strategies for computer system validation and how to increase overall system productivity. The 10-step risk-based validation approach will be detailed so that the specific documents for a validation project are understood. The webinar will detail...
WEBINAR
MAR
03
10:00 AM
Objectionable Microorganisms: Considering the Risk
Online Event, Palo Alto, CA, USA
This webinar on objectionable microorganisms will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is. Why Should You Attend: Due to increased scrutiny by the FDA and other regulatory agencies, companies must now determine how to reduce the risk if they find objectionable microorganisms. This webinar will provide an expert's insight into reducing this risk. GMPs require that products be free of objectionable microorganisms and it is incumbent upon manufacturers to ensure their...
WEBINAR
FEB
26
10:00 AM
Are Your Criminal Background Checks Legally Compliant?
Online Event, Palo Alto, CA, USA
This course will instruct attendees on conducting employee background checks that protects you from negligent hiring liability. This webinar will help you understand and appreciate the legal issues you must be aware of and discuss some best practices so that you can ensure compliance on all fronts. Why Should You Attend: Most of your employees are likely to be honest and reliable. At the same time, hiring employees always involves at least some risk. Are they honest? Are they reliable? Are you, your employees and your clients safe if you hire them? Hopefully your worst hire was simply...
SEMINAR
FEB
26
8:30 AM
How to get a CLIA Waiver for your Medical Device: One and a Half Day In-person Seminar
, San Diego, CA, USA
Course Description: FDA has granted precious few applications for waiver since their CLIA Waiver guidance was published on January 30, 2008. Between 2008 and 2012, FDA reviewed 34 applications for CLIA Waiver and approved 14, sometimes taking years to issue a denial. The cost of performing CLIA Waiver studies, combined with the lengthy review times and likelihood of failure, has discouraged companies from bringing new innovations to this critical public health sector. With the CLIA Waiver guidance appearing to be so prescriptive, why has denial dominated the review outcome? By attending...
SEMINAR
FEB
26
8:30 AM
Detecting and Preventing Asset Misappropriation and Financial Statement Fraud
, Tampa, FL, USA
Course Description: This highly interactive two day seminar on fraud detection and prevention will: Review fraud schemes used to commit financial statement fraud and misappropriate assets from organizations. Discuss fraud schemes committed by employees, customers, vendors, management, and outsiders. Review various internal controls that can help prevent and detect these types of fraud. Explain the procedures for performing a risk assessment for fraud . Present case studies of specific frauds that cover how the fraud occurred, how the fraud was discovered, and what could have been done...
WEBINAR
FEB
25
10:00 AM
The Compliance of Satisfaction – Work-Life Effectiveness
Online Event, Palo Alto, CA, USA
This personal development webinar will help you understand your work-life effectiveness, health, wellness, strategic work life planning along with career management. You will learn how to strike the right balance in today’s stressful work environment. Why Should You Attend: And in today’s fast-paced, competitive and market-driven work environment, a work-life effectiveness plan can create health, disease resilience and more time to devote to your directions and priorities. This webinar will ensure that you will be fully aware of how-to hold yourself responsibility, accountability and...
WEBINAR
FEB
25
10:00 AM
The FDA Inspection: Preparation, Management, and Follow-Up
Online Event, Palo Alto, CA, USA
This course will discuss the limitations of FDA’s scope during an inspection, and best practices for preparing for an inspection and what to do during a close-out interview. It will also list FDA guidance documents used by inspectors during inspections. Why You Should Attend: Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? An FDA inspection can be a nerve-wracking experience for a regulatory professional. However, adequate...
WEBINAR
FEB
20
1:00 AM
FDA's Pet Food Labeling Guidelines
Online Event, Palo Alto, CA, USA
This webinar will discuss the legal requirements for labeling pet or animal food. It will cover aspects of labeling such as the product name, the guaranteed analysis, the nutritional adequacy statement, feeding directions, and calorie statements. Why Should You Attend: Pet owners and veterinary professionals have a right to know what they are feeding their animals. The pet food label contains a wealth of information, if one knows how to read it. Food processors and food manufacturers have the responsibility to ensure that pet food is produced in compliance with FDA regulations. The FDA in...
WEBINAR
FEB
19
10:00 AM
E-Payments - Complying to Auditor's Standards
Online Event, Palo Alto, CA, USA
This E-payments compliance training will dig in to the emerging market of electronic payments, invoicing, and workflow and how that relates to the myriad of requirements from internal and external auditors. Why Should You Attend : Is your current Accounts Payable process doing everything they can to streamline their staff and be as efficient as possible? With any new technology comes the question of compliance. Electronic Payments have become so common in many industries that auditors not only like the process but prefer it over traditional means of Accounts Payable processing. The less...
WEBINAR
FEB
17
10:00 AM
A Unified Approach to Complaints, Servicing, and FDA Reporting
Online Event, Palo Alto, CA, USA
This FDA inspection training webinar provides practical advice on the FDA requirements for complaints. It explores the problems that can trigger FDA reports such as Medical Device Reports (MDRs), Corrections Reports, and Removals Reports. On the servicing side we explain the requirements to analyze service reports, show how they can trigger MDRs, and automatically become complaints. Why Should You Attend: As an added bonus, the webinar will include the newly proposed regulations for electronic filing of MDRs, the eMDR program. The “new” FDA, under Dr. Hamburg, is increasing enforcement...
WEBINAR
FEB
13
10:00 AM
Ensuring Regulatory Compliance of Food Establishments
Online Event, Palo Alto, CA, USA
This webinar will outline proactive measures that food processors can use to comply with FDA regulatory requirements and be audit ready any time, and not just when an inspection or audit is expected. FDA inspections are usually unannounced, so the better a company is prepared, the more likely it can ensure regulatory compliance. Why Should You Attend: Managers and employees involved in food processing activities should receive adequate training in processing and packaging technologies that they are involved in as well as updates on Good Manufacturing Practice requirements pertaining to the...
WEBINAR
FEB
13
10:00 AM
Writing and Implementing Statistical Analysis Plans (SAPs)
Online Event, Palo Alto, CA, USA
This training on clinical trial Statistical Analysis Plans (SAP) will review writing, timing and specific content of the SAP in the context of FDA guidance based on ICH E9 with references to ICH E3 and E6. We will work through a sample template and discuss how to approach each section for maximum clarity and ease of interpretation at the end of a study. Why Should You Attend: The statistical analysis plan (SAP) is a key component of a clinical trial. It is a prospective plan of statistical methods not detailed in the Protocol. While the protocol is primarily concerned with design...
WEBINAR
FEB
12
10:00 AM
Civil Monetary Penalties and Exclusion
Online Event, Palo Alto, CA, USA
This webinar will explain the Civil Monetary Penalties Law (CMP) and its mandatory and permissive exclusions and penalties. It will also cover obligations under EMTALA, violations of the Anti-Kickback Statute and Stark including amendments under the PPACA. Why Should You Attend: This session is designed for healthcare executives, physicians and other healthcare providers who participate in and receive remuneration from Medicare, Medicaid, and other federal healthcare programs such as TriCare. As a healthcare executive, physician or other healthcare provider, you should be very concerned...
WEBINAR
FEB
12
10:00 AM
The 6 Most Common Problems in FDA Software Validation and Verification
Online Event, Palo Alto, CA, USA
This FDA Software Validation and Verification training/webinar will review the validation planning process with particular emphasis on avoiding six common pitfalls. Why Should You Attend: FDA inspectors are now being trained to evaluate software validation practices. Increasing use of automated manufacturing and quality systems means increased exposure. Most recalls can be traced back to computerized equipment, exposing the validation process to scrutiny. Corporate uncertainty leads to inaction and 'wheel spinning'. A third of recent warning letters included citations with respect to...
SEMINAR
FEB
12
8:30 AM
Effective and Efficient Internal and Supplier Quality System Auditing for Medical Devices
, San Diego, CA, USA
Course Description: Do you want to understand how to do efficient and effective internal and supplier audits that meet all the requirements of your external auditors, but also add value to your company? Are you confused by all the requirements and guidance documents for medical device quality management systems and are tired of wading through all the regulatory language they contain? Do you need to train new auditors for your medical device quality management systems or to audit your suppliers? Do you need to improve the training of your internal and supplier auditors so that they add...
SEMINAR
FEB
12
8:30 AM
Key GMP Systems in Pharmaceutical and Biotech Labs: 2-Day In-person Seminar
, Philadelphia, PA, USA
Course Description: This workshop will provide the audience with an overview of the key systems which have been mentioned by FDA inspectors as major areas of concern in FDA regulated pharma laboratories. The topics addressed will include FDA requirements for OOS investigations, equipment program, pharmaceutical and biologics stability programs, method validation and handling regulatory inspections. During the discussion of each of the areas listed below, the workshop participants will work through a series of related FDA 483s to fully understand FDA expectations and the errors which lead to...
WEBINAR
FEB
11
12:00 PM
Teaching your Front-line How to Ask BSA Questions?
Online Event, Palo Alto, CA, USA
This Bank Secrecy Act training will explain how to train your frontline staff to ask BSA questions. It will cover Currency Transaction Report (CTR), Monetary Instrument Log (MIL) and Suspicious Activity Report (SAR) scenarios and questions and much more. Why Should You Attend: Because the frontline of any financial institution is the first line of defense, it stands to reason that ill-trained frontline staff will, in essence, be the collapse of your institution. A strong and well educated frontline staff will help develop a strong back office BSA department for your financial institution....
WEBINAR
FEB
11
10:00 AM
Stability Program to Support Shipping and Distribution of Drug Products
Online Event, Palo Alto, CA, USA
This training on pharmaceutical stability studies will highlight the key factors that would affect the shipping and distribution of drug products. It will explain the stability studies that need to be done to support shipping and distribution of drugs. Why Should You Attend: A drug product must maintain its identity, strength, quality and purity till its expiration. Physical, chemical and biological data are influenced by various environmental factors such as temperature, humidity and light. In current manufacturing environment, products can be shipped and distributed across different...
WEBINAR
FEB
11
10:00 AM
Corporate Governance Law 101 for Top Management to Monitor Compliance
Online Event, Palo Alto, CA, USA
This webinar will instruct attendees on best practices for corporate governance to monitor and ensure compliance. It will detail what investors and regulators look for in proper governance procedures and documents. The session will follow a business entity from inception through its operations to growth and/or sale and explain how the company should be managed by its board and how this management should be documented. Why Should You Attend: As our business entities become more sophisticated in response to the complexity of the world in which we operate, more is expected of the way we...
WEBINAR
FEB
11
10:00 AM
Prevention of Infection in Healthcare Workers
Online Event, Palo Alto, CA, USA
For healthcare facilities and long term care facilities looking to promote employee safety and infection control in the workplace, this webinar will provide essential inputs on structuring your employee health program as per Center of Disease Control (CDC), Occupational Health and Safety Administration (OSHA), Centers for Medicare and Medicaid Services (CMS), and the National Institute for Occupational Safety and Health (NIOSH) recommendations. Why Should You Attend: The CDC, OSHA, CMS and NIOSH have set guidelines, regulations or requirements for healthcare organizations to ensure the...
WEBINAR
FEB
10
10:00 AM
Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing
Online Event, Palo Alto, CA, USA
This 90-minute webinar will show how you can design a robust microbiological audit program for pharmaceutical and biopharmaceutical product manufacturing, that effectively assesses your facility and that of your supplier to ensure your facilities and products are free from microbial contamination. Why Should You Attend: The risk of non-compliance related to microbiological causes is too great, in terms of fines, potential law suits, loss of consumer confidence, and ultimately, the bottom line. This means that biopharmaceutical manufacturers must prove that their facilities and products are...
WEBINAR
FEB
10
10:00 AM
Regulatory Perspectives of Clinical Project Management
Online Event, Palo Alto, CA, USA
This 90-minute webinar will provide an overview of regulatory management for clinical trials. It will discuss key regulatory aspects of a clinical project such as clinical protocol management, IRB management, safety reporting, rules for recruitment programs, seeking advice from FDA, trial master files, and training requirements. Why Should You Attend: Clinical project managers need to have clear perspective of what may be needed for assuring compliance with FDA requirements of a given clinical trial at all times. Non-compliance with these requirements could lead to rejection of the trial...
SEMINAR
FEB
09
8:30 AM
OCEG approved GRC (Governance, Risk and Compliance) Professional Seminar
, San Francisco, CA, USA
Course Description: This GRC Professional Seminar will teach you how to efficiently design and enhance GRC activities within your organization based on established GRC standards and an internationally recognized framework. This program will enhance your credentials by helping you qualify for the GRC Professional certification exam, offered by GRC Certify. Through lectures, practical group interaction, discussions, and exercises, participants will learn to: Define a GRC strategy Integrate and improve corporate performance, and risk and compliance programs Strengthen core business...
WEBINAR
FEB
06
10:00 AM
3-hr Virtual Seminar: Latin America - Understanding Regulatory Compliance Requirements
Online Event, Palo Alto, CA, USA
This Latin America regulatory compliance requirements training will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America. Why Should You Attend: This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Latin America. The primary countries covered will include: Argentina, Brazil and Mexico. Other countries such as Chile, Costa Rica, Dominican Republic, Panama, Peru and Venezuela will...
WEBINAR
FEB
06
10:00 AM
21 CFR 11 Compliance for Excel Spreadsheet
Online Event, Palo Alto, CA, USA
This Excel spreadsheet compliance training will outline the FDA requirements for Excel spreadsheets used in regulated environments and provide guidance on 21 CFR Part 11 validation. Why Should You Attend: Spreadsheet applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel spreadsheet...
WEBINAR
FEB
06
9:00 AM
Blinding of Investigational Materials
Online Event, Palo Alto, CA, USA
This webinar will introduce attendees to the basics concepts and techniques of blinding of investigational drug products. It will also provide an understanding of the complexities of the work required to prepare blinded products for clinical trials. Why Should You Attend: How do you go about masking the identity of a drug? How do government regulations affect the blinding process? What type of testing is needed to assure drug integrity? What are my options and how do I select the proper method of blinding? What is a double dummy design? Do placebos have to be blinded? How do I blind...
WEBINAR
FEB
06
9:00 AM
Clinical Trial Liability Lawsuits
Online Event, Palo Alto, CA, USA
This hour-long session will provide insights on liabilities arising due to non-compliance and oversight in clinical trials. The clinical affairs expert will also discuss identifying the types of litigation and how best to eliminate the source of risk with real world examples. Participants will learn to appreciate the importance of formal training in conducting proficient clinical trials. Why Should You Attend: There are several types of injury that can arise in clinical trials that sponsors, investigators and staff should be aware of so that they can avoid them. Understanding the sources of...
WEBINAR
FEB
05
10:00 AM
Guidelines for Performing a Corporate Wide Internal Audit Risk Assessment
Online Event, Palo Alto, CA, USA
Performing a corporate wide risk assessment is doable, and can provide internal audit and its organization a roadmap for the upcoming audit year. In this webinar, participants will learn how to maximize the time spent on the risk assessment process on an annual basis. Why Should You Attend: Performing a corporate wide risk assessment can seem like a daunting task for an organization. In reality, it can be done using a template and brainstorming with internal auditors, certified fraud examiners and business unit leaders throughout your organization. Understanding your company’s risk...
WEBINAR
FEB
05
10:00 AM
Telehealth and Regulation of Health Care Services Delivered via Telehealth
Online Event, Palo Alto, CA, USA
In recent years, there has been an increase in the delivery of health care services via telehealth to bridge distance and time and provide better follow on and more conveniently accessible care to patients. This webinar will provide an overview of telehealth services by health care providers and U.S. federal and state government regulation of the delivery of health care via telehealth. Why Should You Attend: This growing mode of care delivery in which providers and patients are not in close physical proximity has drawn interest from policymakers and regulators charged with protecting...
WEBINAR
FEB
04
10:00 AM
Creating a Global Regulatory Plan
Online Event, Palo Alto, CA, USA
This regulatory training will help attendees understand key benefits for implementing and maintaining an effective global regulatory plan. Attendees will also gain exposure to the elements and a methodology for global regulatory plan development and maintenance. Why Should You Attend: How many of us have jumped into pursuing a new market before knowing the regulatory requirements and impact? If you have, you are not alone. Mapping the requirements as part of your strategic planning may help you identify a great new market or help you avoid a costly mistake. This webinar will discuss...
WEBINAR
FEB
03
10:00 AM
Changing Supplier Controls Requirements
Online Event, Palo Alto, CA, USA
This training on FDA supplier controls will help you refine your supplier chain management and vendor audits to match the FDA's tougher position. We will evaluate the chief areas of change to see how to better prepare a supplier chain management and audit program. Why Should You Attend: Recent FDA statements and actions indicate the past ways of managing a company's supply chain / outsourcing will no longer be acceptable. Increasingly reports from the field indicate that the agency is using high-profile cases to drive compliance to smaller companies and suppliers. CGMP compliance cannot be...
WEBINAR
JAN
30
10:00 AM
Healthcare Fraud and Abuse Practical Perspectives, Prevention, Detection and Reporting
Online Event, Palo Alto, CA, USA
This webinar will explain the laws that regulate Fraud, Waste, and Abuse (FWA) including the Stark law. Attendees will learn how to detect, prevent and report healthcare fraud and abuse. Why Should You Attend: Health care fraud is an intentional misrepresentation, deception, or intentional act of deceit for the purpose of receiving greater reimbursement. Health care abuse is reckless disregard or conduct that goes against and is inconsistent with acceptable business and/or medical practices resulting in greater reimbursement. This webinar will help attendees to identify fraud early, root...
WEBINAR
JAN
30
10:00 AM
IRS Reporting Requirements: 1098s, 1099s, W-2, Tax Filling and More
Online Event, Palo Alto, CA, USA
This course will detail the reporting requirements for information forms that must be filed each year. Attendees will learn the proper procedures for submitting information forms to the IRS and form recipients. Why Should You Attend: When it comes to reporting requirements concerning information forms, the IRS is very specific about: How information should be reported on information forms Who has to file information forms Using the appropriate forms Filing procedures for these forms Any organization filing 250 or more information forms is required by law to electronically file the...
WEBINAR
JAN
29
10:00 AM
Foreign Corrupt Practices Act (FCPA) and International Anti-Bribery Course
Online Event, Palo Alto, CA, USA
This course will cover the requirements of the Foreign Corrupt Practices Act (FCPA) and other national and international anti-bribery laws and treaty provisions. The webinar is part of a two-course training session, where the first segment will help attendees understand the provisions of the FCPA and other foreign anti-bribery laws, as well as those actions that are exempt from prosecution. The second segment will test participants’ understanding of the these laws using practical examples, real cases and enforcement actions, such as those involving U.S. retailers, infrastructure and gas and...
WEBINAR
JAN
29
10:00 AM
Smart Manager's Guide to Reading, Understanding and Interpreting Financial Statements
Online Event, Palo Alto, CA, USA
The numbers contained within the various types of financial statements of a business can help identify the business’ strengths and weaknesses. This program is designed for the benefit of controllers, chief financial officers, and lenders who rely on the information contained in financial statements to make lending, borrowing and other financial decisions. Why Should You Attend: In today’s business environment, understanding ‘the numbers’ is essential. This webinar will detail the financial information that is contained within profit and loss statements, balance sheets and cash flow...
WEBINAR
JAN
29
10:00 AM
Canadian Advertising and Marketing of Pharmaceuticals
Online Event, Palo Alto, CA, USA
This webinar will provide attendees an overview of the relevant statutes, including the Competition Act, Food and Drugs Act and relevant regulations and information about the existence and operation of Canadian advertising pre-clearance agencies. The rules around advertising and marketing health products will be explained using examples, and hot topics in advertising and marketing will be covered, including the use of social media, testimonials and endorsements. Why Should You Attend: This advanced webinar will cater to all companies in the health product industry (including external...
WEBINAR
JAN
29
10:00 AM
Preparing the Challenging Form 990
Online Event, Palo Alto, CA, USA
This course will discuss complex issues related to nonprofit taxation which are reported in Form 990. It will further elaborate IRS and state issues, including penalties, dissolution, examinations, and improper classifications of tax exempt status. Best practices to expedite the preparation of the return and electronic filing requirements will be highlighted in the webinar. Why Should You Attend: The object of this course is to train both new and experienced staff accountants and other preparers to deal with the challenges of filing the Form 990 series of tax returns. Attendees will learn...
WEBINAR
JAN
29
9:00 AM
ORM Maturity Model - What Does Good Look Like?
Online Event, Palo Alto, CA, USA
Regulators, executives, and boards have raised the bar for operational risk programs. There has been frustration from all key stakeholders with the perceived lack of value. It’s critical that there is a realistic expectation and picture of a truly mature program. It is in everyone’s interest to agree upon a true maturity level that is sustainable, attracts talent and is attainable in line with business direction. Why Should You Attend: Business management and regulators are, in general, dissatisfied with ORM’s performance; it has created obstacles for the profession and caused...
SEMINAR
JAN
29
8:30 AM
Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency
, San Diego, CA, USA
Course Description: FDA views risk management as an essential process both during inspections and in the review of pre-market submissions. Effective risk management has become critical to medical device manufacturers and this interactive two day seminar is aimed at providing medical device professionals with the tools necessary for effective risk management implementation in device manufacturing and marketing. It will address both the fundamentals of risk management as well as current best practices for ISO 14971 compliance. The course will look in detail at risk management requirements in...
SEMINAR
JAN
29
8:30 AM
Latin America: Regulatory Compliance Requirements for Life Science Products
, San Francisco, CA, USA
Course Description: This two-day comprehensive Course on Latin America Regulatory compliance requirements will cover topics ranging from pre-clinical and clinical requirements through product registration, amendments and renewals across Pharmaceuticals, Biologics, Medical Devices and Combination Products. The Course will address the structure of the regulatory agencies in Latin America and discuss local cultural nuances to help you be successful in working with the regulators. Note: Use coupon code 232082 and get 10% off on registration. For more details >>
WEBINAR
JAN
28
10:00 AM
HIPAA Omnibus Update - Tracking Down the Details
Online Event, Palo Alto, CA, USA
The new omnibus update to the HIPAA regulations now in effect contains numerous changes based, for the most part, on The HITECH Act passed in 2009. Some of the most significant changes for medical offices have to do with changes to individual rights under HIPAA that require changes in policies and procedures and must be properly noted in your forms and notices. All HIPAA privacy policies and notices of privacy practices (NPP) must be updated to meet the new rules. This course will describe the schedule of implementation and scope of the changes. Why Should You Attend: This webinar will...
WEBINAR
JAN
28
10:00 AM
Electronic Device & Social Media Rules for Banks and Financial Firms
Online Event, Palo Alto, CA, USA
Learn why and how to develop and implement a strategic ePolicy program, combining written rules, employee training, and technology tools. This session will guide attendees in minimizing email, social media, mobile device, and web risks within an organization, while maximizing compliance and communication. Why Should You Attend: This training will arm participants with the tools necessary to develop a strategic electronic compliance management program, designed to minimize risks, maximize compliance, and manage behavior and content. Additionally, the course will focus on: Providing a...
WEBINAR
JAN
28
10:00 AM
A Bulletproof, Cost-Efficient Supplier Management Program
Online Event, Palo Alto, CA, USA
This webinar will review in detail the FDA QSR and ISO requirements for supplier evaluation and assessment, and discuss cost effective options for many of the common practices for achieving compliance. Why Should You Attend: Supplier qualification and assessment is required according to both QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this. Organizations can, however, spend much less time and money, and still be in control of their suppliers and in compliance with the regulations. This presentation will review the QSR...
WEBINAR
JAN
28
10:00 AM
Effect of the Marijuana Laws in the Workplace - Mary Jane Brought Pot Brownies!
Online Event, Palo Alto, CA, USA
More than fifteen states have passed medical marijuana laws, and more are on the way. Even if your state does not have current marijuana legislation, a clear understanding of the present status of marijuana and medical marijuana under the federal and state laws is essential. This course will offer participants a broad overview of the proposed regulatory model for medical marijuana laws and drug testing policies, using case laws to illustrate the same. Why Should You Attend: In stark contrast to the “Just Say No” 1980’s, the past two years has seen an explosion of medical marijuana...
WEBINAR
JAN
28
10:00 AM
Your AML Program is Being Audited, Now What?
Online Event, Palo Alto, CA, USA
From OFAC procedures to account opening, client vetting and transaction monitoring, the regulatory obligations laid upon a financial institution are many. With that comes the inevitable review of the effectiveness of your program as a whole and its application in particular. This program will assist you in developing a plan to deal with this process. Understanding the application of the program to your institution, the corresponding regulatory requirements and the tools you use all go a long way in dealing with and substantiating your position that your program is sufficient and effective for...
WEBINAR
JAN
27
10:00 AM
Veterinary Medical Devices and FDA Regulatory Oversight
Online Event, Palo Alto, CA, USA
This course will discuss the regulatory requirements for marketing and selling veterinary medical devices in the U.S. Attendees will learn how to adhere to the safety standard applicable to a device and how to appropriately label a veterinary medical device to comply with FDA requirements. Why Should You Attend: The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) has regulatory jurisdiction over veterinary medical devices and has shown little interest in the market sector based on the existence of historical enforcement action. However, with the growing marketing...
WEBINAR
JAN
27
10:00 AM
Detecting and Preventing Embezzlement in Your Organization
Online Event, Palo Alto, CA, USA
While there are innumerable ways to detect, prevent and investigate embezzlement, it is not always easy to organize a consistently effective anti-embezzlement strategy. This webinar will guide you through the common and not-so-common forms of embezzlement—with uniquely instructional case studies. It will emphasize the red flags of each and go on to highlight best practices in embezzlement risk mitigation. Why Should You Attend: This course will highlight several types of embezzlement, how it can be committed and by whom. It will enable participants to identify: The step-by-step process...
WEBINAR
JAN
27
10:00 AM
If It Wasn't Documented It Didn't Happen: Legal & Effective Discipline & Documentation
Online Event, Palo Alto, CA, USA
This webinar will help managers master the art and science of performance documentation. You will learn about safe, legal, & effective disciplinary practices & documentation. Why Should You Attend: In our litigious society, it has become more and more important for managers to know how to document and discipline employees to avoid law suits and manage employee performance effectively In this 60-minute webinar, Judi gives managers a “crash course” in safe, legal, and effective disciplinary practices and documentation. You will learn how to separate poor performance from poor attitude,...
WEBINAR
JAN
27
8:00 AM
Correcting W-2 and 941 and How to Successfully Prepare and Report 941
Online Event, Palo Alto, CA, USA
This webinar will review the legal and regulatory changes for the 2014 reporting year. The course will focus on best practices for gathering, calculating and reconciling W-2 data and to prepare Form W-2c efficiently. Why Should You Attend: Claims of errors need to be taken seriously, reviewed and corrected immediately. The risk of errors on Form W-2 continues to increase as the tax code becomes more complex (ACA, MSRRA, reconciliation acts, etc.). It is very important to keep current with these changes to reduce the risk of errors and be able to better communicate proper reporting to your...
WEBINAR
JAN
26
10:00 AM
The Role of the Audit Committee in Corporate Governance
Online Event, Palo Alto, CA, USA
Audit committees are a fundamental part of the proper governance of any organization, together with the executive management and internal as well as external audit. This webinar will explore the role of the audit committee in corporate governance and risk management. Why Should You Attend: This role, of necessity, involves ensuring that the risk management process remains both comprehensive and ongoing instead of the annual process that is implemented in many organizations. Corporate policies regarding legal compliance, compliance with corporate codes of conduct, and conflicts of interest...
WEBINAR
JAN
23
10:00 AM
FDA’s Proposed Preventative Control Regulation for Human Food under FSMA
Online Event, Palo Alto, CA, USA
This webinar will summarize the regulatory requirements for FDA’s proposed new regulation – “Current Good Manufacturing Practice and Hazard Analysis and Risk Based Preventative Controls for Human Food” - 21CFR Part 117. The GMP component of this regulation (Subpart B) is intended to replace the current outdated GMP regulation (21CFR Part 110) when it becomes effective, as expected, in 2015. Why Should You Attend: Part 117, Subpart B (GMPs) contains some new requirements for food processors not required by Part 110. Many definitions in the current Part 110 have been changed or added...
WEBINAR
JAN
23
10:00 AM
New Requirements for Sponsors and Laboratories for Analyzing Clinical Trial Samples to Meet GCP
Online Event, Palo Alto, CA, USA
This webinar will help clinical laboratories, analyzing samples from clinical trials, understand the compliance requirements concerning ICH GCP for FDA and EMA (new requirements 2012) compliance. Why Should You Attend: As a result of the FDA and EU Clinical Trials Directive 200/20/EC and subsequent promulgation of laws, EMA inspection and reflection paper in clinical laboratories in the EU covering the conduct of clinical trials in accordance with Good Clinical Practice (GCP), there is the need for laboratories undertaking analysis of samples from clinical trials to comply with GCP...
WEBINAR
JAN
23
10:00 AM
A Systematic Approach To Writing Effective Standard Operating Procedures (SOPs)
Online Event, Palo Alto, CA, USA
This FDA compliant SOPs training will explain how to write, organize, and maintain Standard Operating Procedures (SOPs) and train personnel so that you can ensure FDA compliance in a way that is concise, reproducible and easy to follow. Why Should You Attend: Standard Operating Procedures (SOPs) are required by law for companies that are regulated by the Code of Federal Regulations such as Title 21 and Title 493. Yet there is no guidance on how to write, organize and maintain SOPs. Consequently, SOPs are frequently written in a way that makes compliance difficult or downright impossible....
WEBINAR
JAN
23
10:00 AM
OSHA Enforcement for Employers Using Temporary Workers
Online Event, Palo Alto, CA, USA
This workplace safety compliance training will explain OSHA’s initiative to protect temporary workers. It will also provide you the tools to ensure compliance with OSHA requirements when employing temporary workers. Why Should You Attend: Under this initiative, OSHA has instructed its Compliance Officers to ask employers during all inspections about whether temporary workers are employed at the work site. If they are, the inspection will focus on the compliance issues presented by using temporary workers. It is therefore important to understand the issues underlying the use of temporary...
WEBINAR
JAN
23
10:00 AM
Analyzing Financial Statements for Fraud
Online Event, Palo Alto, CA, USA
This webinar will provide attendees insights on analyzing financial statements and reports for fraud. Attendees will learn to look at a financial statement with a knowledgeable outlook to understand its author’s motives. Why Should You Attend: Unscrupulous business people often produce fraudulent and misstated financial statements when: attracting investors to the company obtaining financing and/or credit extensions for a business avoiding default on loan covenants selling a business involved in litigation trying to avoid disclosing failed management decisions increasing their...
WEBINAR
JAN
22
11:00 AM
Deviations: What are they? Do you need to report?
Online Event, Palo Alto, CA, USA
This webinar will help you clearly understand, classify and determine what deviations to report in clinical studies. It will also explain, in detail, the terminology applied to deviations. Why Should You Attend: As the human subjects regulatory framework continues to grow and be further defined, it is important to know when and what needs to be submitted, reviewed, and approved by an Institutional Review Board (IRB) prior to implementation by the study team. Alternatively, as studies become more complex and complicated the study team often has to make immediate decisions which may not allow...
WEBINAR
JAN
22
10:00 AM
Effective Behavioral Interviewing: Seeing Past the Surface
Online Event, Palo Alto, CA, USA
Selecting the best applicant who is the right match for your organization is vital to your organization’s success. This session will review effective interviewing strategies that can apply to all positions, including legal dos and don’ts for interviewing that expand beyond the human resources office. Why Should You Attend: Some of the key areas that will be addressed in this presentation include: As interviewers, what can we do to get past applicant's canned answers? Are applicants really answering our questions, or just telling us what we want to hear? How do we manage first...
WEBINAR
JAN
22
10:00 AM
New AML Schemes to Detect and Prevent Fraudulent Transactions
Online Event, Palo Alto, CA, USA
From terrorist funding to drug cartels and everything in between, fraudsters are getting more sophisticated in laundering money. Consequently, AML has come under much scrutiny. This webinar will offer an overview of the AML process and will detail the kinds of internet fraud. The instructor will highlight how virtual banks put organizations at risk and focus on detailing best practices to use latest technology to detect and prevent fraudulent transactions. Why Should You Attend: Given the rapid technological advances, you can conduct your business at any time and from any place with your...
WEBINAR
JAN
22
10:00 AM
EU Clinical Trial Regulation: New Requirements
Online Event, Palo Alto, CA, USA
This course will present attendees with a clear understanding of the new processes and requirements for EU sponsors of clinical trials as the new regulation is published, rolled-out and implemented by the Member States, the European Medicines Agency and the European Commission. Why Should You Attend: This course will cover the newly proposed requirements for conducting clinical studies across the EU via the requirements of the EU Clinical Trial Regulation 536/2014 (for drugs, biologics and combination products). The course will also cover recent updates on EU-GCP associated with the...
WEBINAR
JAN
22
10:00 AM
21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Eliminate 483s
Online Event, Palo Alto, CA, USA
This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach). Why Should You Attend: This webinar will describe exactly what is required for compliance with Part 11 and the updated European equivalent Annex 11. It will take the concepts described in the regulations and expand them into specifics for all three primary compliance areas: SOPs, product features, and validation. Attendees will learn what is required for IT, SaaS, and cloud hosting. All...
WEBINAR
JAN
22
10:00 AM
Credit card surcharging
Online Event, Palo Alto, CA, USA
This training on credit card surcharges compliance will discuss how the recent changes in law will affect end-user organizations. It will also provide attendees with the tools necessary to review and deal with any potential surcharge/checkout fee situations. Why Should You Attend: Surcharging had been historically prohibited in the U.S. per the networks' merchant rules, as well as prohibited by law in 10 states. Any state laws will continue to "trump" networks' merchant rules. The recent changes in surcharging law could not only affect your merchant processing transactions but also your...
WEBINAR
JAN
22
10:00 AM
Alternatives for Financing Export Sales
Online Event, Palo Alto, CA, USA
This webinar will showcase best practices for streamlining an organization’s export sales finance to increase sales effectively and improve cash flow with minimum risk. Why Should You Attend: Learn how to better negotiate and structure commercial sales in foreign markets to simultaneously increase sales, limit risks, and improve cash flow. This webinar will examine tools that enable otherwise intolerable transactions by limiting payment and performance risks and tapping funding sources that are specifically designed for export sales. It will elucidate the motives of the seller, the...
WEBINAR
JAN
22
9:00 AM
Life Safety Code – ESRD
Online Event, Palo Alto, CA, USA
This course will analyze the guidelines set by the LSC-ESRD (Life Safety Code - End Stage Renal Disease) for the safety of dialysis patients in high risk environments. Participants from the healthcare industry will be updated on this standard and learn how to stay in compliance with these norms. Why Should You Attend: The Life Safety Codes for ESRD was developed to ensure compliance with the most current regulations for the safety of dialysis patients in high risk environments for fire and hazard risks. This webinar will cover the development of the LSC-ESRD guidelines. CMS is prepared to...
SEMINAR
JAN
22
8:30 AM
BSA/AML/OFAC Risk Assessments - Are You Doing Them Correctly: One and Half Day In-person Seminar
, San Francisco, CA, USA
Course Description: Although financial institutions have been managing BSA operations as per the regulatory requirements, the change in focus to appropriate BSA/AML/OFAC risk assessment has become increasingly important. Regulators look to the organization for insurance and evidence that BSA operations are appropriately performing risk assessments. Appropriate risk assessments are essential in an organization’s strategic planning and development, as well as ensuring compliance with laws and regulations. This Bank Secrecy Act risk assessment seminar will highlight BSA best practices that...
WEBINAR
JAN
21
10:00 AM
How Audit Evaluation Can Ensure Effective Decision Making Under Uncertainty
Online Event, Palo Alto, CA, USA
This presentation will explore the nature of decision making in crisis situations. It will explore the psychology of decision making under stress and overview risk management analysis tools. The webinar instructor will present tips and techniques to identify structural and cyclical changes, improve risk management strategy processes, and identify transparent vulnerabilities. Why Should You Attend: The webinar will emphasize the different stages that employees go through before taking action in a crisis. Building on this understanding, the instructor will illustrate to participants how best...
WEBINAR
JAN
21
10:00 AM
Verification vs. Validation in Regulated Industries
Online Event, Palo Alto, CA, USA
This webinar on verification vs. validation will help you to understand the differences between, and benefits of, verification and validation in both design and process operations in regulated industries. Learn about the risks and complications involved with the application of sound verification and validation principles. Why Should You Attend: Companies wishing to understand the risks and complications involved with the application of sound verification and validation principles will gain a better understanding of the differences and benefits by attending this training. The meanings and...
WEBINAR
JAN
21
10:00 AM
Child Support: What Payroll Doesn't Know Can Hurt You
Online Event, Palo Alto, CA, USA
This HR compliance training will focus on the child support garnishments compliance requirements and will help attendees accurately and completely process garnishment orders through the payroll department in compliance with Federal and state requirements and regulations. Why Should You Attend: Compliance with Child Support Garnishments can be some of the most complex tasks required of any payroll department. If not handled correctly, you may find yourself facing situations that become extremely costly both financially and emotionally! Courts, federal and state regulations, bureaucracies,...
WEBINAR
JAN
21
10:00 AM
Affordable Care Act New Tax Penalties: Impact on Individuals and Employers
Online Event, Palo Alto, CA, USA
This webinar will instruct participants on the new penalties issued to individuals and employers who lack coverage altogether or whose healthcare coverage fails to meet Affordable Care Act (ACA) standards. Attendees will also learn how to compute the required annual payment, i.e., the shared responsibility payment. This two-hour webinar will focus on requirements set forth for individuals and employers filing the new form 1095-C. Why Should You Attend: The penalty on individuals who lack coverage altogether or whose coverage fails to meet ACA standards will kick in with the 2014 filing...
WEBINAR
JAN
21
9:00 AM
From Chaos to Organized: Whip Those Physician Contracts into Shape
Online Event, Palo Alto, CA, USA
This healthcare compliance training will explain how to organize and negotiate physician financial arrangements in order to be ready for internal and external audits. Attendees will learn how to comply with regulatory requirements of Stark Law, the Anti-kickback statute, the False Claims Act (FCA), and IRS tax-exemption code related to physician arrangements. Why Should You Attend: Financial arrangements that exist between physicians and healthcare providers (e.g., hospitals) to which they refer patients have been the focus of Office of Inspector General and other regulatory agencies for...
SEMINAR
JAN
21
8:30 AM
Risk Based Internal Auditing (RBIA): 2-day Comprehensive Workshop
, Dubai - Dubai - United Arab Emirates
Course Description: The Institute of Internal Auditors defines Risk Based Internal Auditing (RBIA) as a methodology that links internal auditing to an organization’s overall risk management framework. RBIA allows internal audit to provide assurance to the board that risk management processes are managing risks effectively, in relation to the risk appetite. But every organization is different. There are different attitudes to risk, different management and organizational structures, different processes and procedures, and the need to subscribe to and comply with different conventions and...
WEBINAR
JAN
20
10:00 AM
Monitoring and Measuring Customer Satisfaction Using ISO 10004:2012
Online Event, Palo Alto, CA, USA
Although customer satisfaction is not deemed a critical area for medical device manufacturers, measuring and monitoring customer satisfaction can determine issues that hinder progress. This training session will elaborate the methods to identify customer expectations, list techniques to analyze customer satisfaction data, and cite preventive action for improvement. Why Should You Attend: Quality management systems (QMS), FDA QSR and ISO 13485:2003 do not require customer satisfaction measurements as regulators are not in a position to enforce it. It is still important, however, and could...
WEBINAR
JAN
20
10:00 AM
Evolving Regulatory Expectation for Particulates in Biologics
Online Event, Palo Alto, CA, USA
This webinar will discuss the evolving regulatory requirments for testing Biologics injectibles for sub-visible Particulates. Why Should You Attend: There is an increased scrutiny on the testing and reporting of particulates in Protein Therapeutics. Proteinaceous Particulates in Biologics injectibles can arise from the aggregation of the protein product and can be induced by silicone droplets, metal particles and glass particles. Aggregates in protein products present a safety concern because they may increase the immunogenicity of the product. The FDA has therefore requested BLA sponsors...
WEBINAR
JAN
20
10:00 AM
Microbiological Risk: Do I Really Need to Test Raw Materials for Microorganisms
Online Event, Palo Alto, CA, USA
This webinar will cover the regulatory perspective in testing raw materials for microorganisms and how you can manage the risk of raw materials being the major source of microbial contamination in your medical product manufacturing process. Why Should You Attend: Raw materials are often the major source of microbial contamination that is introduced into the manufacturing process. Raw materials of natural origin, such as animal and plant source, support an extensive and varied microflora. Some of these pose a risk to the product and patient. This webinar will address the regulatory and...
WEBINAR
JAN
19
10:00 AM
Payroll Record Keeping: Who Requires What, for How Long and in What Format
Online Event, Palo Alto, CA, USA
Personnel records are documentation of an individual's employment history encompassing all employment-related information collected and maintained by the employer. These essential documents form the foundation upon which employment actions are based. This webinar will illustrate key concepts in managing personnel records to protect your organization from potential exposure and security threats. Why Should You Attend: Employers are often confused concerning the legal requirements for recordkeeping, the retention of employee files and other employment-related records. Apart from federal...
SEMINAR
JAN
19
8:30 AM
Risk Management - Focus on Fraud: 2-Day Comprehensive Workshop
Hyatt Regency Dubai, D 85, Al Khaleej Rd, Deira - Dubai - United Arab Emirates
Aims: Fraud figures high on the list of operational risks that face all banks and financial institutions. This course will look at recent events to see two very clear examples of massive frauds – Bernard Madoff and Satyam. There are of course many others, but these two stand out because of their size and linkage to the present continuing financial crisis. How would you fare if your bank or organization was faced with a fraud? In fact could you even identify a fraud in your working environment? Are you maximizing your staffs’ potential to reduce fraud and error in your systems? A major...
WEBINAR
JAN
16
11:00 AM
Operational Risk Scenario Analysis
Online Event, Palo Alto, CA, USA
Scenario analysis complements the risk assessment process, which often overlooks material events that only happen infrequently, such as natural disasters, acts of terrorism, and data breaches. This webinar will highlight the importance of scenario analysis, its objectives and expected benefits, and the ideal methodology for quantifying and reporting operational risk scenarios. Why Should You Attend: Scenario analysis has become an important tool in the practice of operational risk management. Subject matter experts develop and analyze unlikely but plausible extreme events that might result...
WEBINAR
JAN
16
10:00 AM
Import Audit Compliance Focused Assessment
Online Event, Palo Alto, CA, USA
This training will address the import record-keeping and audit compliance procedures that will emphasize the importer obligation to maintain and assess internal and external records that are related to their international trade transactions. Why Should You Attend: For small and medium-sized manufacturers facing record-keeping audit and assessment challenges in meeting Ports of Entry and U.S. Import Regulations, this webinar will: Provide import compliance materials that examine U.S. Customs and Border Protection regulations for record-keeping that can be used in the international...
WEBINAR
JAN
16
10:00 AM
Anti-Kickback, Fraud, Stark, and Marketing - Where are the Landmines?
Online Event, Palo Alto, CA, USA
This webinar will provide an in-depth understanding of anti-kickback regulations and Stark laws, and discuss how marketing activities can trigger either or both. Why Should You Attend: This webinar will provide the basic building blocks you will need to develop and maintain your company’s precious commodity – your reputation – and eliminate exposure to fraud charges based on marketing practices. It will also cover the practical requirements and operations, principles of compliance and the basic elements that every business has to have to reduce civil and criminal liabilities and...
WEBINAR
JAN
16
10:00 AM
How to Develop an Employee Policy Manual that Fits Your Company Culture
Online Event, Palo Alto, CA, USA
One of the first HR tools a company will install is an employee policy manual. It is important to have a manual and keep it current and reflective of the company, its mission and philosophy. This course will guide attendees in writing policies for different segments of the company, understanding the most common problem areas, and assuring consistent application of the policy. Why Should You Attend: The policy manual should be reviewed and modified constantly as the workplace and its laws and practices change. Parts of the manual are standard, covering basic rules and legal obligations, but...
WEBINAR
JAN
15
10:00 AM
Affordable Care Act Updates: What Employers Need to do to Prepare
Online Event, Palo Alto, CA, USA
For HR representatives and business owners of mid and large sized enterprises, this course will elaborate current trends and updates on the Affordable Care Act. It will emphasize the need for compliance with these updates and list ACA penalties for non-compliance. Why Should You Attend: Health reform is now the law. With key parts of the law going into effect, employers should be prepared to comply with the requirements. This webinar will detail the key but ambiguous aspects of the Affordable Care Act law to help reduce your organization’s risk. Several prime questions and best practices...
WEBINAR
JAN
15
10:00 AM
How to Investigate Environmental Monitoring Excursions
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This OOS investigation training will review the various items that should be included in the investigation to determine the cause of the limit excursion for both viable and non-viable excursions. Why Should You Attend: Medical products are manufactured in environments that control the level of viable and non-viable particulate and to establish that the control is taking place periodic monitoring must be performed. But any time monitoring occurs there is the potential that the results will exceed limits that have been established. The action to be taken when this occurs should be appropriate...
WEBINAR
JAN
15
10:00 AM
Pharmaceutical and Chemical Classification under the Harmonized Tariff Schedule
Online Event, Palo Alto, CA, USA
This course will aid participants in minimizing errors in pharmaceutical and chemical classification under the Harmonized Tariff Schedule (HTS). It will help better protect your company during import/export audits from the government. Participants will also learn how to take reasonable care as an importer and become aware of best practices and red flags in the area of classification for imports into the United States. Why Should You Attend: The Harmonized Tariff Schedule (HTS) is used by over 200 countries, territories, or customs unions around the world to assign a number to each product...
WEBINAR
JAN
15
10:00 AM
The Sunshine Act Reporting for Clinical Trials
Online Event, Palo Alto, CA, USA
This webinar will discuss the disclosure requirements for clinical investigators under the Sunshine Act. It will discuss the details of the processes; provide templates for reporting formats; and timelines for reporting. Why Should You Attend: The Sunshine Act exposes the physicians and sponsors to new reporting requirements which are unprecedented in their scope and detail noncompliance to which would lead to hefty fines. This webinar will summarize the new requirements and provide practical solutions to most common situations that are prevalent and necessary between sponsors and...
WEBINAR
JAN
15
10:00 AM
How to Mitigate Risk Against the Crime of Financial Facilitation of Criminal Activity
Online Event, Palo Alto, CA, USA
Criminals and criminal enterprises constantly manipulate the banking system to move their illegal proceeds through financial institutions. Their methods and trends are always changing, so investigative personnel, accountants, auditors, and FIU personnel need to be aware of these activities. This course will instruct attendees on how to examine each transaction to determine the method, the reason, and potential destination of the funds to protect financial institutions during personal and business transactions. Why Should You Attend: As the world around us changes and technology allows us to...
WEBINAR
JAN
14
10:00 AM
Combination Drug/Device Products CGMPs - Final Rule
Online Event, Palo Alto, CA, USA
This training on combination product regulations will evaluate the chief areas of concern or change in the new CGMP requirements for combination products, 21 CFR Part 4, and clarify many of the issues and questions that arise involving combination products. Why Should You Attend: There has been much past confusion on the production and handling of drug / device (and/or biologics) combination products. Companies involved in the production of such products have pieced together what they've considered the applicable elements of the pharma and device CGMPs, 21 CFR 210/211 and 820; sometimes...
WEBINAR
JAN
14
10:00 AM
Investment Performance Risk - Understanding and Evaluating
Online Event, Palo Alto, CA, USA
This course will provide an in depth understanding of the investment performance risk and an examination that addresses how it may exist and the type of risk consequences that can result from actual or perceived substandard investment performance. Why Should You Attend: Investment performance has been the source of numerous client complaints and settlements over the years. With proper management practices many could have been avoided. This presentation will provide participants with: An understanding of the nature of investment performance risk An examination of the factors that can...
WEBINAR
JAN
14
10:00 AM
Identifying & Controlling Electrical Hazards in the Workplace
Online Event, Palo Alto, CA, USA
Engineers, electricians, and other professionals work with electricity directly, including working on overhead lines, cable harnesses, and circuit assemblies. Others, such as office workers and sales people, work with electricity indirectly and may also be exposed to electrical hazards. This course will illustrate OSHA requirements regarding electrical hazards in the workplace. Why Should You Attend: This webinar will discuss electrical hazards in the workplace, and OSHA requirements pertaining to these hazards. It will further address and clarify questions such as: Why is it important...
WEBINAR
JAN
14
10:00 AM
Implementing FDA's 21 CFR 111 for Dietary Supplements
Online Event, Palo Alto, CA, USA
Although FDA's Dietary Supplement Current Good Manufacturing Practice (CGMP) Final Rule 21 CFR Part 111 has been enforced since 2010, manufacturers, distributors and importers are still not completely aware of its impact. This webinar will highlight best practices for implementing 21 CFR 111 for dietary supplements. Why Should You Attend: In 2007, the FDA issued the Dietary Supplement Current Good Manufacturing Practice (CGMP) Final Rule 21 CFR Part 111. Its enforcement commenced in 2010. The rule requires that proper controls be in place for dietary supplements during manufacturing,...
WEBINAR
JAN
14
10:00 AM
Establishing a Culture of Safety for the Surgical Patient
Online Event, Palo Alto, CA, USA
This hour-long session on preventing SSIs to augment safety for surgical patients will discuss introducing a 7 S Bundle approach to your existing quality and safety program. The webinar instructor will define key areas that need to be monitored and risk factors that need to be eliminated to intensify healthcare safety. Why Should You Attend: Guidelines and recommendations for the prevention of surgical site infection (SSI) are published by the CDC, Joint Commission, Society for Hospital Epidemiologist of America (SHEA), American College of Surgeons, Association of Perioperative Registered...
WEBINAR
JAN
13
10:00 AM
Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies
Online Event, Palo Alto, CA, USA
Learn more about FDA’s current audit techniques and the most commonly cited GMP deficiencies that you have to watch out for. The webinar instructor, an FDA and GMP training expert, will help attendees analyze a system of risk assessments to determine audit frequencies. Why Should You Attend: The success of an audit by federal regulators does not always depend on the level of training proffered to staff and department employees, but also in understanding the focus of recent inspections within the industry. Such information provides a template for companies to analyze their own practices...
WEBINAR
JAN
13
10:00 AM
Form I-9 and E-Verify, Getting and Staying Compliant
Online Event, Palo Alto, CA, USA
Today, in order to avoid astronomical fines for non-compliance, employers need to be ever so vigilant and diligent in their process. This webinar discussion will include a review of the penalties ICE and Office of Special Counsel (OSC) can impose. Additionally, the webinar will review paper versus electronic I-9 forms and the common mistakes employers make in the process. Why Should You Attend: Employers are required to complete an I-9 form for every person they hire and to update these forms when necessary. Periodically, the DHS, the Department of Labor, and the Justice Department send...
WEBINAR
JAN
13
10:00 AM
Best Practices to Prevent Fraud
Online Event, Palo Alto, CA, USA
Fraudsters are always looking for new opportunities and new weaknesses. The availability of customer data on the black-market gives them just the tools they need. A bank has responsibilities to its shareholders and customers to protect them from these ever-changing threats. This webinar will furnish attendees with a complete understanding of the changes in the fraud arena and the strategies needed to combat fraud. Why Should You Attend: There are reasons to believe that fraud losses are actually higher than recognized. Banks cannot combat the fraud industry with outdated methods. Some fraud...
WEBINAR
JAN
13
10:00 AM
Principles of Audit Report Writing
Online Event, Palo Alto, CA, USA
This webinar will provide the principles for writing an effective audit report. The audit report represents the end result of weeks of reviews, analyses, interviews and discussions. It is used to provide information to management on the areas you reviewed. And, more importantly, the report brings issues to their attention that needs to be addressed. How well you communicate that information is critical to getting the results you are seeking. Why Should You Attend: An audit report typically represents the conclusion of weeks of reviews, analyses, interviews and discussions. It demonstrates...
WEBINAR
JAN
12
10:00 AM
The Evaluation Trap
Online Event, Palo Alto, CA, USA
This 90-minute webinar will help you identify the flaws in your performance appraisal system and provide practical guidance and tips on how you can rectify it to meet HR and legal compliance requirements. Why Should You Attend: While widely performed, at least in part, to provide organizations with legal protection, performance evaluations are actually typically used in court against the company they are meant to defend. This thought-provoking webinar reveals the fatal flaw in one of HR’s most compliance-driven processes, the performance appraisal system. This session will explain where...
WEBINAR
JAN
12
10:00 AM
The Tools the HR Executive Needs to Build an Internal Complaint System that Gets Results!
Online Event, Palo Alto, CA, USA
This webinar will help HR executives design, establish, and maintain an effective system for handling employee complaints in the workplace based on proven best practices that gets results. Why Should You Attend: This webinar will help you create strategies for derailing those continuous complainers and associates who cannot follow organization policies and procedures that cost managers precious management time paying attention to the small percentage high maintenance workers every group has. The course instructor will provide attendees with tools and best practices every HR executive needs...
WEBINAR
JAN
09
10:00 AM
Implementing Operations Risk Management within an ERM Framework
Online Event, Palo Alto, CA, USA
This webinar will explain what operational risks are, and how to identify, quantify, manage, and control them. We will discuss why all employees must be cognizant of these risks in their day to day jobs and how an organization can better manage and control these risks that have resulted in the failure of several high profile firms and significant losses and unwanted press at others. The course will also review and discuss the building blocks and key players in implementing an effective ORM framework and process. Why Should You Attend: It is a fact that better risk management would in return...
WEBINAR
JAN
09
10:00 AM
How to Balance Respect for Military Service with the Realities of the Workplace
Online Event, Palo Alto, CA, USA
In an era of near constant military activities, employers of all sizes are required to comply with USERRA, the military reemployment rights law. USERRA, implemented by the Department of Justice, is the strictest non-discrimination law on the books. Employers must ensure that they are complying with USERRA if they have any employees who perform military service. Why Should You Attend: In a sea of non-discrimination laws, USERRA, the military reemployment rights law, is unique in that it mandates some of the strictest compliance requirements for employers. So, employers must ensure that they...
WEBINAR
JAN
09
10:00 AM
Gaining and Re-Establishing Control of Your Cleanroom
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This 90-minute webinar will focus on the critical steps in starting up a new cleanroom operation and releasing it for manufacturing. It includes a case study-based approach to dealing with excursion events and establishing control of the cleanroom after a worst case event. Why Should You Attend: This webinar will focus on starting up a new cleanroom operation covering everything from utilities to environmental monitoring. Routine cleaning and disinfection will also be addressed. Addressing contamination and bringing up the cleanroom after a worst case event will be discussed. Cases studies...
WEBINAR
JAN
09
10:00 AM
OSHA Recordkeeping for 2015: Beyond the OSHA 300 Summary
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This webinar will focus on the OSHA recordkeeping requirements. Attendees will learn how to ensure compliance with these regulations and avoid OSHA citations and fines. Why Should You Attend: Most U.S. based organizations have a responsibly to complete specific injury and illness recordkeeping forms as mandated by the Occupational Safety and Health Administration (OSHA). The problem with these forms is that they are usually filled out incorrectly. Over-recording, under-recording and violations of privacy are common mistakes made by organizations and these critical mistakes will result in...
WEBINAR
JAN
08
10:00 AM
Patient Protection and Affordable Care Act Compliance for Large Employers
Online Event, Palo Alto, CA, USA
This webinar will provide an overview of the provisions of the Patient Protection and Affordable Care Act affecting employers of more than 50 to 100 employees. The webinar instructor will discuss and detail the key provisions of the law and the most current federal rules and guidance pertaining to it. Why Should You Attend: As 2015 begins and the new Affordable Care Act mandates take effect, employers need current, updated information to help them fully comply with the law. There has been substantial executive branch action implementing the ACA’s provisions pertaining to...
WEBINAR
JAN
08
10:00 AM
FDA Bioterrorism Act Food Facility Registration
Online Event, Palo Alto, CA, USA
This webinar highlights how the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) directs the FDA, as the food regulatory agency of the Department of Health and Human Services, to take steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies. This regulatory training will instruct attendees on compliance with the requirements of the Bioterrorism Act. Why Should You Attend: This webinar will outline the processes that must be compliant with FDA regulations under the...
WEBINAR
JAN
08
9:00 AM
1099 & W-9 Update - Complying with IRS Information Reporting Guidelines
Online Event, Palo Alto, CA, USA
This IRS regulatory compliance training will focus on the rules requiring W-9 documentation and 1099 reporting. Attendees will learn the best practices to ensure compliance with IRS and avoid B-Notices. Why Should You Attend: What are the rules regarding paying and IRS reporting on independent contractors? How do I avoid the IRS CP-2100 (B-Notices)? What if my vendor claims exemption - must I obtain a W-9 anyway? What are the best practices? How can I minimize risk of improper exemption claims by my vendors? Get the answers to these and related questions to reduce your risk of huge...
WEBINAR
JAN
08
8:00 AM
Bank Secrecy Act (BSA) Audit Best Practices
Online Event, Palo Alto, CA, USA
This BSA audit training will explain how the best practices in a BSA audit have evolved over the years. It will cover the major components of an effective BSA program that the audit focuses on and the specifics of each area as it pertains to BSA audits. Why Should You Attend: Although financial institutions have been managing BSA operations per the regulation requirements, the change in focus to BSA audits has been coming increasingly important. Regulators look to the Bank for assurance and evidence that BSA operations are being appropriately audited to ensure that BSA efforts are...
WEBINAR
JAN
07
10:00 AM
Transform your Organization Carefully with the HR Audit
Online Event, Palo Alto, CA, USA
This webinar will provide attendees with a complete understanding of the HR audit process. It will furnish them with the knowledge, tools, and techniques needed to successfully execute and complete an HR audit. The instructor will offer guidance on effectively developing the workforce in your organization through quality human resource process management. Why Should You Attend: Through this webinar on HR audit best practices, attendees will: Learn how to take the function of human resources from transactional to transitional to transformational Deepen your technical practice...
WEBINAR
JAN
05
10:00 AM
Employee Discharge and Documentation
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Why Should You Attend: Coming to the realization that an employee is not a good fit for your organization, or is not capable of performing the job up to par, is a difficult, confusing and, often, lengthy process. Being supportive about establishing and enforcing clear expectations of performance is challenging and uncomfortable for most supervisors. When done poorly, performance management and terminations can result in discrimination allegations, wrongful discharge claims, and an overall disruption in the workplace. In this course, attendees will learn better ways to set expectations,...
SEMINAR
DEC
11
8:30 AM
Statistical Analysis for Product Development: 2-day In-person Seminar
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Course Description: This course is designed to help scientists and engineers understand the statistical methods used in process and product development. Variability is part of every process, design of experiments helps to separate systematic variability from special cause variability. You will get a chance to examine the different sources of variability how it relates to analytical method development, process improvement and sample size selection. The concept of experimental budget will be introduced to help you plan the total number of experiments needed. You...