GlobalCompliancePanel

Seminar on Designing and Monitoring Approvable Medical Device Protocols

Course "Designing and Monitoring Approvable Medical Device (cardiovascular) Protocols" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Construction of an approvable clinical trial protocol requires excellent scientific writing and organization skills. Also paramount is gathering necessary information to manage the statistical analysis and data management of the study. This usually starts with a literature review, establishing key efficacy and safety parameters and determining proper sample size....

Seminar on Validation and Part 11 Compliance of Computer Systems and Data at Mumbai

Overview: Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory are records are on target of inspectors. The large number of warning letters issued to laboratories also demonstrate that they struggle with either understanding or implementing the regulations. This 2-day course...

Seminar on Modern Approaches to Process Validation

Overview: Companies face many common issues and confusion when creating or revamping their validation programs. Some of these common issues are: Company has expertise in its process validation program but can never quite get is 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, how does the company manage the validation activities (i.e. through...

Conference on Modern Approaches to Process Validation

Copenhagen, NY 13626, USA

Overview: Companies face many common issues and confusion when creating or revamping their validation programs. Some of these common issues are: Company has expertise in its process validation program but can never quite get is 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, how does the company manage the validation activities (i.e. through...

HIPAA Upcoming Changes

San Diego, CA, USA

Overview: We will be discussing the history and evolution of HIPAA Privacy/Security and the major points you need to understand to proactively protect your practice or business from the imminent federal auditing process: Specific areas covered will be: HIPAA now has teeth and funding - a background Be proactive NOT reactive - importance of this based on real life experiences What is involved in a HIPAA audit - from real life events Patients suing under HIPAA - new changes Risk factors to avoid being sued by patients What can you do to limit risks of an audit What to do if you...

Medical Device Complaint Handling

San Diego, CA, USA

Overview: Does your Complaint Management system provide value to your company? It does if your company handles complaints efficiently and effectively - taking them through the reporting, classification, investigation, corrective action, and design change phases. Your system is effective if it recognizes the requirements to report to regulatory agencies (such as FDA, the EU, and Health Canada) and ensures you make the reports on time. An integrated system addresses multiple elements: Designated individuals and their required skill sets Procedures to define the process and standardize...

Product Information for Medicinal Products at Boston

Boston, MA, USA

Overview: Regular review and monitoring of product information for medicines is important, to support awareness of relevant updates/changes which may affect prescribing, dispensing, administration or monitoring practices. It is also important that patients and caregivers, as appropriate, are made aware of the information contained in the Package Leaflet (PL) and should be encouraged to read it prior to and during their treatment. The PL reflects the more comprehensive information described in the SmPC, but is required to be presented in an abbreviated and easyto-read format for...

Seminar on Applied Statistics, with Emphasis on Risk Management in R&D; at Boston, MA

Boston, MA, USA

Overview: The 2-day seminar explains how to apply statistics to manage risk in R&D;, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows: ISO standards and FDA/MDD regulations regarding the use of statistics. Basic vocabulary and concepts. Statistical Process Control Statistical methods for Design Verification Statistical methods for Product/Process Qualification Metrology: the statistical analysis of measurement uncertainty, and how it is used to establish QC...

Seminar on Performing Data Analysis with Multiple Tools at SFO, CA

San Francisco, CA, USA

Overview: The seminar will begin with an over view of data science and many the steps required for collecting, cleaning, organizing and deriving information out of data. The steps are common to all of the tools and will form the foundation for analyzing, comparing and utilizing the tools used in the remainder of the seminar: R, pandas and Deedle. Topics covered in the foundation are: Organizing information into data frames Mutating data frame objects Indexing data frames Data alignment between data frames Handling missing data Joining data Reading and writing data from files and...

Seminar on The DHF, Technical File and Design Dossier - Similarities and Differences at Las Vegas

Las Vegas, NV, USA

Overview: We will consider the following: The Design Control requirements of the CGMPs, 21 CFR 820.30 The Design History File - documenting Product Design Control and its nine elements The Device Master Record and the Device History Record The EU's Medical Device Directive The "Essential Requirements"; and their documentation The remaining elements of a Technical File / Design Dossier Trends Two attendee projects Why should you attend? This seminar / workshop will examine the existing and proposed requirements for the U.S. FDA's DHF -- including its derivative documents, the DMR...

San Francisco Conference on Tougher Import Rules for FDA Imports in 2016

San Francisco, CA, USA

Course "Tougher Import Rules for FDA Imports in 2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: FDA's and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of information and adherence to government procedures. Firm's that fail to understand and properly execute an import and export program find that their shipment is delayed, detained or refused. A number of factors can derail the expectation of a seamless import process....

San Diego Conference on US Medical Device Regulation

San Diego, CA, USA

Course "US Medical Device Regulation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Break Overnight Clinical Trials IDE Other Export for trials Common problems in trial design and management Post marketing QSR CAPA Reporting Inspections Export for foreign markets Pop quiz Give quiz Discuss questions and answers Why should you attend? Have you had the experience of guiding a new product through concept, development, and final design, and, while you are...

Boston Conference on Accreditation to ISO/IEC 17025:2005- Getting There is Only Half the Fun!

Boston, MA, USA

Overview: QMS is the catch phrase for accreditation and is the backbone of ISO/IEC Standard 17025:2005. The Quality System Manual (QSM) is the bible in a QMS environment because, much like its predecessor, Good Laboratory Practice (GLP), it contains the policies that the laboratory is expected to follow to achieve quality results. It is in fact only the "what to do" component of a QMS. What is also needed are the "how to do it" or procedures and methods and finally the controls or evidence that it was done properly. Why should you attend? Many laboratories struggle with developing and...

Minneapolis Conference on Supplier Management for Medical Device Manufacturers

Minneapolis, MN, USA

Course "Supplier Management for Medical Device Manufacturers" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure...

Minneapolis Conference on Supplier Management for Medical Device Manufacturers

Minneapolis, MN, USA

Course "Supplier Management for Medical Device Manufacturers" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure...

Boston Conference on Pharmaceutical Water Systems

Boston, MA, USA

Course "Mastering Biofilm Control, Monitoring, Validation and Excursion Investigations of Pharmaceutical Water Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water...

Surviving an FDA Inspection: Understand the Dos and Donts and the Ground Rules

Boston, MA, USA

Course "Surviving an FDA Inspection: Understand the Do's and Don'ts and the Ground Rules" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This...

Sydney Conference on Validation and Part 11 Compliance of Computer Systems and Data Australia

Hilton Rd, Cambridge Gardens NSW 2747, Australia

Overview: Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory are records are on target of inspectors. The large number of warning letters issued to laboratories also demonstrate that they struggle with either understanding or implementing the regulations. This 2-day course...

Hong Kong Conference on Validation and Part 11 Compliance of Computer Systems and Data

Hong Kong, Hong Kong

Overview: Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory are records are on target of inspectors. The large number of warning letters issued to laboratories also demonstrate that they struggle with either understanding or implementing the regulations. This 2-day course...

St. Louis Conference on Safe Production of Meat Products at Missouri

St Louis, MO, USA

Overview: Educational material discussed during this seminar will include both effective sanitation and hygienic practices and the control of microorganisms that cause spoilage and foodborne illness. After a discussion of microorganisms found in meat products, safety issues will be addressed and contamination sources identified. Practices to reduce contamination such as personal hygiene and Good Manufacturing Practices (GMPs) will be discussed. Sanitation procedures for cleaning after production will be provided and the identification of the optimal cleaning compounds and sanitizers will be...

Texting and E-mail with Patients: Patient Requests and Complying with HIPAA, Maryland

Baltimore, MD, USA

Overview: With the recent advances in portable technology, more and more organizations and their users are taking advantage of mobile devices to save time and get work done more efficiently. Texting, portable e-mail, and Apps are revolutionizing the ways health care providers interact with their patients and get their work done. But the use of these devices comes with hidden costs of compliance, especially if they lead to a reportable breach under HIPAA or state laws. HIPAA Privacy and Security Officers have been struggling to keep up with the use of the devices to protect patient privacy...

San Francisco Conference on Cyber Security Incident Response Program (CSIRT) and Plans

Burlingame, CA, USA

Overview: Cyber Security Incident Response Program is a must for any organization using the Internet. It must be robust yet flexible. Unfortunately in spite of all of the Cyber Events, many companies are taking a long time to respond. Teams must be trained and have written procedures. Time is critical in responding to an incident. Every incident costs the organization, money and reputation. In this session you will learn: Best practices and the standards that make up a great Cyber Incident Response Program Learn what teams should be part of your CSIRT Team Get insight into how to...

Seminar on Equipment, Facility, and Process Qualification and Validation

Florida, USA

Course "Equipment, Facility, and Process Qualification and Validation - A Simple Top to Bottom Sustainable Approach" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Companies face many common issues and confusion when creating or revamping their validation programs. Some of these common issues are: Company has expertise in its process validation program but can never quite get is arms around the facility and equipment changes that require never ending equipment qualification (IQ, OQ,...

Baltimore Conference on Regulatory Compliance for Dietary Supplements in the US, EU and Canada

625 S President St, Baltimore, MD 21202, USA

Course "Regulatory Compliance for Dietary Supplements in the US, EU and Canada" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: The course will cover basic regulatory requirements for marketing of dietary supplements in the U.S. and Canada including product safety, manufacturing, product claims, and labelling requirements. A general overview of EU regulations will also be given.  Why should you attend? In order to successfully market dietary supplements in the U.S. and Canada, it's essential to...

Seminar on HIPAA Privacy Security - Time to Get Serious - Chicago, IL

Course "HIPAA Privacy Security - Time to Get Serious" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: I have conducted over 400 risk assessments for business associates and covered entities alike as well as worked directly with the Federal government in terms of auditing. This seminar will go into great detail about what is going on in the HIPAA Security/ Privacy world. I will discuss why the government is all of a sudden going full bore in demanding compliance. You will learn risk factors to...

Seminar on HIPAA Privacy Security - Time to Get Serious - Chicago, IL

Course "HIPAA Privacy Security - Time to Get Serious" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: I have conducted over 400 risk assessments for business associates and covered entities alike as well as worked directly with the Federal government in terms of auditing. This seminar will go into great detail about what is going on in the HIPAA Security/ Privacy world. I will discuss why the government is all of a sudden going full bore in demanding compliance. You will learn risk factors to...

2-day In-person Seminar on Pharmaceutical Water Systems

Course "The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of...

2-day In-person Seminar on Leadership Certification Training

Overview: In order to qualify as a food safety transportation leader, you will need to understand what and how to implement FDA FSMA rules on the sanitary transportation of human and animal foods. This training will include detailed information on these rules and will include food safety topics generally established by FSMA to assist in your company's approach to transportation tools, load, unload, driver and transportation food safety practices across shippers, carriers and receivers. Over 84,000 businesses will be impacted by these new rules. The shift from "transportation food safety...

Microbial Control, Monitoring, Validation and Troubleshooting Pharmaceutical Water Systems

Course "The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of...

Seminar on Verification vs. Validation - Product Process Software and QMS at Las Vegas, NV

Overview: This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer & tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V;" by sufficient, targeted and documented risk-based V&V; test case elements/scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management. This course will evaluate different field-tested, U.S. FDA-reviewed V&V; protocols; how to employ equipment/process Requirements Specs / DQs, IQs, OQs, &...

Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems

333 Orchard Rd, Singapore 238867

Course "The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems " has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of...

Microbial Control Monitoring Validation and Troubleshooting of Pharmaceutical Water Systems

Course "The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of...

2-day In-person Seminar on Clinical Drug Development and Approval Process at San Diego, CA

Overview: Drug development is the process of incorporating data from multiple disciplines into a logical and coherent argument for the efficacy and safety of a drug product resulting in regulatory approval. The course will focus on the clinical aspect. The primary goal of the course will provide students with the basic principles and process for taking a chemical and developing it into a drug product. Medical, pharmaceutical, pharmacokinetics, and statistical principles will be reviewed and utilized in the course. Examples will be provided by my experience, experiences in the literature, and...

Software Risk Analysis Tools for Medical Devices and Risk Mitigation at San Diego

Overview:   The FDA recalls related to software performance are on the increase for at least five years at the time of this writing. Software failures were behind 24 percent of all the medical device recalls in 2011, according to data from the FDA. Similar to hardware, software also has hazards (any source of harm) and hazardous situations which transform a hazard into harm. We must identify hazards and identify what event can turn them into harm and write software specifications to prevent such combinations. The risk management tools such as FMEA (Failure Mode and Effects Analysis), FTA...

Seminar on Validation and Part 11 Compliance of Computer Systems and Data at Zurich, Switzerland

Overview: Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory are records are on target of inspectors. The large number of warning letters issued to laboratories also demonstrate that they struggle with either understanding or implementing the regulations. This 2-day course...

Seminar on The 3 C's of Audit Report Writing at Washington, DC

Overview: This 2-day session will appeal to beginners and experienced professionals who want to formulate great audit reports as well as executives and investors who need to unlock the valuable secrets of a key audit report. From understanding the preliminary steps, through the necessary interviews and information gathering stages, to actually writing the audit report that uses the 3 c's (context, clarity, customization, you will be given a formula to follow that delivers predictable and valuable results. You will also be given practical examples and an opportunity to practice your new...

Seminar on Tougher Import Rules for FDA Imports in 2015 at Washington, DC

Overview: FDA's and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of information and adherence to government procedures. Firm's that fail to understand and properly execute an import and export program find that their shipment is delayed, detained or refused. A number of factors can derail the expectation of a seamless import process. The course covers detailed information about the roles and responsibilities of the various parties involved with an import operation and how to correct the weakest link(s) in the...