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Dr Steven S. Kuwahara President of GlobalCompliancePanel

 

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Upcoming events:

GlobalCompliancePanel created an event

CONFERENCE

MAY

21

9:00 AM

GMP and Regulatory Expectations for Early IND Products

Boston, MA, Boston, MA, USA

Overview: This course will present, in one place, the regulations and guidelines that apply to early phase products. In some cases these will not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. The course will present these items in the order of product development from the point of R & D activities to the completion of Phase 2 clinical trials. Why should you attend: Any pharmaceutical worker who must deal with products both in early and latter phases of development should attend this course in order...

Medical Devices
Drugs and Biologics
Clinical and Laboratories
Pharmaceutical
Cosmeceutical
Food Safety
Marketing and Sales
GlobalCompliancePanel created an event

SEMINAR

MAY

21

9:00 AM

Clinical Trials and Clinical Product Development in the EU: Regulatory Affairs Aspects

Zurich, Switzerland, Zurich, Switzerland

Overview: The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan. In this Seminar it is explained how to write the regulatory plan, and which aspects to consider. The regulatory plan describes the regulatory strategy, as well as pricing and reimbursement issues in your development. Orphan medicinal Products will be discussed, and the advantages of having a status as an orphan medicinal product will be explained. Scientific advice is a vital element in the development of a medicinal product, and knowledge of the how to choose between...

compliance training
online compliance
training solutions
compliance courses
training solutions online
Regulatory Affairs Aspects
Clinical Trials
GlobalCompliancePanel created an event

SEMINAR

MAY

21

9:00 AM

Seminar on Medical Device Software Development at Boston, MA

Boston, MA, Boston, MA, USA

Overview: This seminar is mainly based on the IEC62304:2006 standard and will introduce the main elements and requirements for the development of modern software systems for medical devices. Emphasis is placed on understanding the underlying principles that generate the requirements of the standard, to understand strengths, the shortcomings and weak parts of the standard and give practical, proven guidance on how to implement the requirements necessary for regulatory approval. This seminar goes beyond teaching the mere content of the standard, but will provide the toolset to understand the...

Medical Device Software Development
Medical Device Training
Medical device conference
FDA Compliance Training
FDA Regulatory Training
GlobalCompliancePanel created an event

SEMINAR

MAY

28

10:00 AM

2-day In-person Seminar on Why You Should be worried about HIPAA at SFO, CA

SFO, CA, San Francisco, CA 94128, United States

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. Specific areas covered will be: ·         History of HIPAA ·         HITECH ·         HIPAA Omnibus Rule ·         How to perform a HIPAA Security Risk Assessment ·         What is involved in a Federal audit and how is it conducted ·         Risk factors for a federal audit ·         EHR and HIPAA ·         Business Continuity/Disaster...

HIPAA Compliance Training
HIPAA Regulatory training
mastering hipaa security rule
Regulatory Compliance Training
HIPAA Compliance Conference
HIPAA Compliance Seminars
GlobalCompliancePanel created an event

SEMINAR

JUN

04

9:00 AM

Human Subjects Research Seminar: Current Regulations under FDA and HIPAA at San Diego, CA

DoubleTree by Hilton Hotel San Diego Downtown, 1646 Front St, San Diego, CA 92101, USA

Overview: This two day seminar will provide the foundation for the application, concepts and theories of clinical research. Within the two days, attendees will learn about the historical evolution of research, current regulations and guidelines including the Common Rule, FDA regulations and HIPAA. We will discuss site and study staff responsibilities in the conduct and reporting of research, types of studies and the regulatory requirements that apply to different study designs. We will discuss a variety of research including genetic, drug, device, and studies that use off-site or community...

compliance training
online compliance
training solutions
compliance courses
training solutions online
FDA Training
Regulatory Training
GlobalCompliancePanel created an event

SEMINAR

JUN

04

9:00 AM

2-day In-person Seminar on Extracting Information from Geochemical Data at Salt Lake City, UT

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Overview: Most specialists strongly recommend to sample every meter of the drill core or of a trench and to use multi element analysis, rather than just asking the laboratory for gold test. There are also many other types of analysis that are ignored by the industry. But even when such analyses are requested, most of the time the fed geologist is not well trained on the necessary techniques and methods to extract all the information contained in the data. This seminar will teach you what to ask and how to extract all the important information of your data Why should you attend? You, as a...

compliance training
online compliance
training solutions
compliance courses
training solutions online
FDA Training
Regulatory Training
GlobalCompliancePanel created an event

SEMINAR

JUN

04

9:00 AM

Seminar on Quality Assurance for Microbiological Laboratories at Chicago

Courtyard Chicago O'Hare, 2950 S River Rd, Des Plaines, IL 60018, 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? By the end of this 2-day interactive workshop,...

compliance training
online compliance
training solutions
compliance courses
training solutions online
FDA Training
Regulatory Training
GlobalCompliancePanel created an event

SEMINAR

JUN

08

9:00 AM

2-day In-person Seminar on Using Statistical Methods for ICH Guidelines at Barcelona, Spain

Hilton Barcelona Hotel, Avinguda Diagonal, 589, 08014 Barcelona, Barcelona, Spain

Overview: This hands-on course will provide attendees with an understanding of how to apply statistical methods to the ICH Q series guidelines. The course will deliver tools, templates and insight that will allow participants to immediately begin implementation within their organization/firm.  This 2 day hands-on workshop explores the unique challenges facing all facts of a pharmaceutical or biotechnology company. Practical implementation solutions as well as best practice descriptions that will allow management to effectively assess, manage and mitigate risk of poorly designed studies....

compliance training
online compliance
training solutions
compliance courses
training solutions online
FDA Training
Regulatory Training
GlobalCompliancePanel created an event

SEMINAR

JUN

11

9:00 AM

Seminar on International Trade - Strategies to Enhance Financing and Operational Success

Boston, MA, Boston, MA, USA

Overview: Upon completing this course participants should: ·         Understand how to identify international trade opportunities; when you see lead from the Commerce Dept. validate it with due diligence by asking hard questions to validate the leads. ·         Utilize International trade to build revenues through sales and profit maximization. ·         Evaluate effectiveness, suitability and adaptability of implemented solutions/corrective actions by implementing project management and/or CRM solutions ·         Receive a tool box of methods to...

International Trade Shows
Financing and Operational Success
Regulatory Compliance
Regulatory Conferences
Regulatory Semianrs
GlobalCompliancePanel created an event

SEMINAR

JUN

18

9:00 AM

2-day In-person Seminar on Submitting Marketing Applications in Canada at Seattle, Washington

Courtyard Seattle Sea-Tac Area, 16038 W Valley Hwy, Tukwila, WA 98188, USA

Overview: Topics included will include the filing of New Drug Submissions for various types of pharmaceutical companies, priority submissions, organization of Health Canada, process for approval of applications, timeframes and cost for approval. We will cover the review of New Drugs and Old Drugs. Also included will be Natural Health Products. Canada has pricing controls, unlike the US. Reimbursement in Canada is very much related to the healthcare system in Canada. An overview of reimbursement will be covered. Why should you attend? Understanding the process in Canada for the registration...

compliance training
online compliance
training solutions
compliance courses
training solutions online
FDA Training
Regulatory Training
GlobalCompliancePanel created an event

SEMINAR

JUN

18

9:00 AM

Design of Experiments (DOE) for Process Development and Validation at Seattle, WA

Seattle, WA, Seattle, WA, USA

Overview: Prior to developing a process control plan as part of an overall risk management strategy, process development studies must be completed. The objective of these process development studies is to gain knowledge and understanding about how variation in process parameters explains variation in the product quality characteristics of the product. The use of DOE methodology provides a means to identify process parameters which impact product quality (critical process parameters) and determine the functional relationship that links the process parameters to that critical quality...

Design of Experiments (DOE)
Compliance Training
Regulatory Compliance Training
FDA Compliance Training
Verificationand Validation
GlobalCompliancePanel created an event

SEMINAR

JUN

25

9:00 AM

Promotion of Biomedical Products: Regulatory Considerations at Baltimore, MD

Baltimore, MD, Baltimore, MD, USA

Overview: This course provides a basic overview of the laws and regulations affecting the advertising and promotion of drugs, biologics, and medical devices. It is specifically designed to clearly illustrate how the law and regulations are applied on an everyday basis without having to read through volumes of "legal-ese" text. Why you should attend: This course provides a basic overview of the laws and regulations affecting the advertising and promotion of drugs, biologics, and medical devices. It is specifically designed to clearly illustrate how the law and regulations are applied on an...

Promotion of Biomedical Products
Regulatory Considerations
Medical Device Training
Regulatory Compliance Training
Compliance Training
GlobalCompliancePanel created an event

SEMINAR

JUL

02

9:00 AM

Seminar on How to Conduct Medical Device Risk Analysis Effectively at SFO, CA

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Overview: Why companies are prone to having past problems in new devices? One of the main reasons seems to be the �weak cognition.� It is usually the result of short term memory, inattention to details, insufficient vigilance, or multitasking. This unsafe work propagates unknowingly because of not engaged or disengaged employees, insufficient understanding of customer needs, splitting design among several designers, and ineffective risk analysis. Another big reason is that ineffective device management procedures often touted as 'best practices', are like a bad virus with long incubation...

Compliance Training
FDA Regulations Training
FDA Compliance
Regulatory Compliance Training
ComplianceOnline
Compliance Webinars
Online Webinars
GlobalCompliancePanel created an event

SEMINAR

JUL

09

9:00 AM

Applied Statistics for QA, QC, Manufacturing, and Design Control at SFO, CA

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Overview: The 2-day seminar begins with an examination of ISO and FDA regulations and guidelines regarding the use of statistics. Basic vocabulary and concepts are then reviewed and discussed. The flow of subsequent topics over the 2 days is as follows: How to calculate confidence intervals (for proportions and for measurements), including a discussion of how to choose sample size How to perform an interpret t-Tests, including consideration of "significance", "p-values", "power" and sample-size considerations How to perform calculation of confidence/reliability for attribute data How...

Compliance Training
FDA Regulations Training
FDA Compliance
Regulatory Compliance Training
ComplianceOnline
Compliance Webinars
Online Webinars
GlobalCompliancePanel created an event

SEMINAR

JUL

09

9:00 AM

Design of Experiments (DOE) for Process Development and Validation at Singapore

,

Overview: Prior to developing a process control plan as part of an overall risk management strategy, process development studies must be completed. The objective of these process development studies is to gain knowledge and understanding about how variation in process parameters explains variation in the product quality characteristics of the product. The use of DOE methodology provides a means to identify process parameters which impact product quality (critical process parameters) and determine the functional relationship that links the process parameters to that critical quality...

Compliance Training
FDA Regulations Training
FDA Compliance
Regulatory Compliance Training
ComplianceOnline
Compliance Webinars
Online Webinars
GlobalCompliancePanel created an event

SEMINAR

JUL

16

9:00 AM

Problem Solving and Root Cause Analysis - the Key to an Effective CAPA System at San Diego, CA

DoubleTree by Hilton Hotel San Diego Downtown, 1646 Front St, San Diego, CA 92101, USA

Overview: This program is designed to provide participants with: ·         Understanding and developing an effective Corrective and Preventive Action System ·         An understanding of a structured problem solving process ·         Tools and techniques to perform root causes analyses ·         The use of facts and data to eliminate the use and identification of ineffective solutions. An 8-Step Process is presented during the program, consisting of: 1.     Identify the Problem 2.     Identify the Team 3.     Contain the...

Compliance Training
FDA Regulations Training
FDA Compliance
Regulatory Compliance Training
ComplianceOnline
Compliance Webinars
Online Webinars
GlobalCompliancePanel created an event

SEMINAR

JUL

16

9:00 AM

Tougher Import Rules for FDA Imports in 2015 at San Diego, CA

DoubleTree by Hilton Hotel San Diego Downtown, 1646 Front St, San Diego, CA 92101, USA

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...

Compliance Training
FDA Regulations Training
FDA Compliance
Regulatory Compliance Training
ComplianceOnline
Compliance Webinars
Online Webinars
GlobalCompliancePanel created an event

SEMINAR

JUL

16

9:00 AM

Seminar on Applied Statistics for Scientists and Engineers at Zurich, Switzerland

Zurich, Switzerland, Zurich, Switzerland

Overview Throughout 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries, the application of statistical methods are specified for: setting validation criteria and specifications, performing measurement systems analysis (MSA), conducting stability analysis, using design of experiment (DOE) for process development and validation, developing process control charts, and determining process capability indices. Different statistical methods are required for each of these particular applications. Data and tolerance intervals are common tools used...

Compliance Training
FDA Regulations Training
FDA Compliance
Regulatory Compliance Training
ComplianceOnline
Compliance Webinars
Online Webinars
GlobalCompliancePanel created an event

SEMINAR

JUL

23

9:00 AM

Why You Should be worried about HIPAA at Washington, DC

Courtyard by Marriott Capitol Hill/Navy Yard, 140 L Street Southeast, Washington, DC 20003, 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. Specific areas covered will be: ·         History of HIPAA ·         HITECH ·         HIPAA Omnibus Rule ·         How to perform a HIPAA Security Risk Assessment ·         What is involved in a Federal audit and how is it conducted ·         Risk factors for a federal audit ·         EHR and HIPAA ·         Business Continuity/Disaster...

Compliance Training
FDA Regulations Training
FDA Compliance
Regulatory Compliance Training
ComplianceOnline
Compliance Webinars
Online Webinars
GlobalCompliancePanel created an event

SEMINAR

JUL

30

9:00 AM

Statistical Techniques for Medical Device Manufacturers at Philadelphia, PA

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Overview: The FDA's Quality System Regulation (QSR) requires device manufacturers to identify valid statistical techniques to "establish, control, and verify the acceptability of process capability and product characteristics." When device manufacturers analyze CA&PA; information, they must also use "appropriate statistical methodology". Some manufacturers are not clear about all of this. Others are nervous that their approach is sufficient. In addition, sampling plans must be valid, documented, adequate, and reviewed based on changes. These issues can create a patchwork of techniques...

Compliance Training
FDA Regulations Training
FDA Compliance
Regulatory Compliance Training
ComplianceOnline
Compliance Webinars
Online Webinars
GlobalCompliancePanel created an event

SEMINAR

AUG

06

9:00 AM

The Statistics of- Design Verification, Process Validation, and Statistical Process Control at SFO

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Overview: This 2-day seminar provides a 1-day introduction to the statistical tools used to analyze Design Verification data and Process Validation results. The 2nd day is spent on Statistical Process Control and Process Capability Indices. The goal of the 1st day is to help the student understand how to choose statistical methods and sample sizes, and to correctly interpret the results. The goal of the 2nd say is to explain how to monitor a validated production process, using tools that will also help improve the product. Why should you attend? All design and/or manufacturing companies...

Compliance Training
FDA Regulations Training
FDA Compliance
Regulatory Compliance Training
ComplianceOnline
GlobalCompliancePanel created an event

SEMINAR

AUG

06

9:00 AM

Seminar on Personal Work Retreat - Refresh, Refocus, and Reactivate at SFO

,

Overview: With all of the deadlines, projects, and tasks that you have to do every day at work, it's hard to find time to set personal development goals that positively impact your work performance and help you to grow professionally. But how will you advance in your career if you don't make time for values clarification, goal setting, and increasing productivity? Without a concrete plan in place, you are at risk of stagnating in your current position and experiencing burnout. Taking a personal retreat is an effective and time-efficient strategy for moving your career forward and recharging...

Compliance Training
FDA Regulations Training
FDA Compliance
Regulatory Compliance Training
ComplianceOnline
GlobalCompliancePanel created an event

SEMINAR

AUG

06

9:00 AM

Construction - Construction Hazards & Basics, for any Jobsite at SFO

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Overview: Real world examples of what to expect, and what to prepare for whenever possible. Not every organization is ready to avoid inspections or fines if they do not have senior staff in place, and/or if they have not been audited in the past. How to train staff to have the correct documentation in place. Ensure that the organization keeps documentation updated and realistic. If an employee is nervous and informs the inspector/auditor wrong information, a strong documentation system will support all of the proper steps that are in place. What to strive for and whom to ask for help and...

Compliance Training
FDA Regulations Training
FDA Compliance
Regulatory Compliance Training
ComplianceOnline
GlobalCompliancePanel created an event

SEMINAR

AUG

20

8:30 AM

Promotion of Biomedical Products: Regulatory Considerations at Los Angeles

Doubletree by Hilton Hotel Los Angeles Downtown, 120 S Los Angeles St, Los Angeles, CA 90012, USA

Overview: This course provides a basic overview of the laws and regulations affecting the advertising and promotion of drugs, biologics, and medical devices. It is specifically designed to clearly illustrate how the law and regulations are applied on an everyday basis without having to read through volumes of "legal-ese" text. Why you should attend: This course provides a basic overview of the laws and regulations affecting the advertising and promotion of drugs, biologics, and medical devices. It is specifically designed to clearly illustrate how the law and regulations are applied on an...

Compliance Training
FDA Regulations Training
FDA Compliance
Regulatory Compliance Training
ComplianceOnline
GlobalCompliancePanel created an event

SEMINAR

AUG

20

9:00 AM

International Trade: Strategies to Enhance Financing and Operational Success at Los Angeles

DoubleTree by Hilton Hotel Los Angeles Downtown, 120 S Los Angeles St, Los Angeles, CA 90012, USA

Overview: Upon completing this course participants should: ·         Understand how to identify international trade opportunities; when you see lead from the Commerce Dept. validate it with due diligence by asking hard questions to validate the leads. ·         Utilize International trade to build revenues through sales and profit maximization. ·         Evaluate effectiveness, suitability and adaptability of implemented solutions/corrective actions by implementing project management and/or CRM solutions ·         Receive a tool box of methods to...

Compliance Training
FDA Regulations Training
FDA Compliance
Regulatory Compliance Training
ComplianceOnline
Finance and Banking
GlobalCompliancePanel created an event

SEMINAR

AUG

20

9:00 AM

Software Risk Analysis Tools for Medical Devices and Risk Mitigation at Chicago

Courtyard Chicago O'Hare, 2950 S River Rd, Des Plaines, IL 60018, USA

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...

Compliance Training
FDA Regulations Training
FDA Compliance
Regulatory Compliance Training
ComplianceOnline
GlobalCompliancePanel created an event

SEMINAR

AUG

27

9:00 AM

ISO/IEC 17025-2005 and Laboratory Accreditation at Boston

Courtyard Boston Logan Airport, 225 William F McClellan Hwy, Boston, MA 02128, 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...

Compliance Training
FDA Regulations Training
FDA Compliance
Regulatory Compliance Training
ComplianceOnline
GlobalCompliancePanel created an event

SEMINAR

AUG

27

9:00 AM

The Job of the Corporate Controller in Today's Environment at SFO

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Overview: Prepare yourself to take on the role of the Corporate Controller. Your career path offers you the opportunity to step into this position, but it comes with risks. Do you really know what it takes to move up to this highly visible leadership role? Invest in your future and join us to learn exactly what it takes to successfully transition into this key position. Identify the necessary core competencies of the role and become more self-assured as you work to properly define this role for you and your company. This is a practical seminar designed for financial professionals on the...

Compliance Training
FDA Regulations Training
FDA Compliance
Regulatory Compliance Training
ComplianceOnline

+

Past events:

GlobalCompliancePanel created an event

CONFERENCE

MAY

14

9:00 AM

Preparing to Comply with the New FDA FSMA Rules on the Sanitary Transportation of Human

Chicago, IL, Chicago, IL, USA

Overview: Transportation and Logistics food transportation food safety rules are currently being finalized by the U.S. Food and Drug Administration (FDA). Under congressional instructions, the Food Safety Modernization Act (FSMA) requires the FDA to establish rules to improve, audit and enforce new food transportation rules. The rules provide a significant focus on foods not completely enclosed by a container, risk reducing adulteration prevention, personnel training and certification, inspection and data collection, maintenance and reporting that provides evidence of compliance. These...

Medical Devices
Drugs and Biologics
Clinical and Laboratories
Pharmaceutical
Cosmeceutical
Food Safety
Marketing and Sales
GlobalCompliancePanel created an event

CONFERENCE

MAY

14

9:00 AM

Seminar on The A to Z's of Writing and Enforcing Effective SOPs (Standard Operating Procedures)

Courtyard Chicago O'Hare, Chicago, IL, USA

Overview: Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function." Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? If you are...

Medical Devices
Drugs and Biologics
Clinical and Laboratories
Pharmaceutical
Cosmeceutical
Food Safety
Marketing and Sales
GlobalCompliancePanel created an event

CONFERENCE

MAY

07

9:00 AM

FDA Inspections: Before, During and After - In-person Comprehensive Workshop

Four Points By Sheraton French Quarter, New Orleans, LA, USA

Overview: FDA's inspection program follows well-established procedures and conducts the inspections with as much consistency as possible. FDA trains its investigators from day one. During the first six months, they attend extensive classroom and hands on training. FDA investigators learn basic skills. As time goes on, special training is given and the field staff use detailed reference materials to guide their thinking, actions, decisions and conclusions. If you understand FDA's management of its investigators and inspectional process, you can keep your establishment ahead of a needless...

Medical Devices
Drugs and Biologics
Clinical and Laboratories
Pharmaceutical
Cosmeceutical
Food Safety
Marketing and Sales
GlobalCompliancePanel created an event

SEMINAR

APR

23

9:00 AM

Accreditation to ISO/IEC 17025:2005- Getting There is Only Half the Fun! - 2-day In-person Seminar

Courtyard By Marriott Dallas DFW Airport North/Irving, 4949 Regent Blvd, Irving, TX 75063, 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...

Accreditation to ISO/IEC 17025
Quality System Manual (QSM)
QMS environment
Good Laboratory Practice (GLP)
Management Components of a QMS
Marketing and Sales
GlobalCompliancePanel created an event

SEMINAR

APR

09

9:00 AM

Managing Advanced Research & Development - 2-day Comprehensive Workshop

DoubleTree by Hilton Hotel Los Angeles Downtown, 120 S Los Angeles St, Los Angeles, CA 90012, USA

Overview: This webinar will cover issues concerning industrial / scientific labs describing the differences between manufacturing and scientific labs. It will also discuss how management relates to the labs and the types of products they produce. It will describe how the types and productivity of the labs will fare in the coming age of technology, artificial intelligence and autonomy varies. Describe how one does a cold start, starting a lab from nothing. Advanced research and Labs overlap but they are not quite the same thing. How your Lab Advanced Research people will relate to...

Managing Advanced Research
Managing Advanced Research & Development
Defense Advanced Research Projects Agency (DARPA)
Defense Threat Reduction Agency (DTRA)
National Research Councils
University Space Research
Management
GlobalCompliancePanel created an event

SEMINAR

APR

09

9:00 AM

2-day In-person Workshop on Enforcing Effective SOPs (Standard Operating Procedures)

DoubleTree by Hilton Hotel Los Angeles Downtown, 120 S Los Angeles St, Los Angeles, CA 90012, USA

Overview: Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function." Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? If you are...

Standard Operating Procedures
Enforcing Effective SOPs
Medical Devices
Drugs and Biologics
Clinical and Laboratories
Pharmaceutical
Marketing and Sales
GlobalCompliancePanel created an event

SEMINAR

APR

09

9:00 AM

2-day In-person Seminar - The A to Z's of Microbial Control, Monitoring

DoubleTree by Hilton Hotel Los Angeles Downtown, 120 S Los Angeles St, Los Angeles, CA 90012, USA

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 necessary. The instructor can provide the background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, and maintenance of a high purity water system. Without this understanding, water system design and control are merely managed by a set of rules that often don't work and can...

Pharmaceutical Water Systems
A to Z's of Microbial Control
FDA Compliance
Microbial Enumeration Issues
microbiological education Training
Management
Marketing and Sales
GlobalCompliancePanel created an event

SEMINAR

MAR

19

9:00 AM

Complaint-Handling, MDR and Recall Management - 2-day In-person Seminar

DoubleTree by Hilton Hotel San Diego Downtow, 1646 Front St, San Diego, CA 92101, USA

Overview: An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of problems with the use, design, and/or...

Complaint-Handling
Medical Device Reporting
FDA
Clinical Affairs Training
Medical Device Recall Reporting
GlobalCompliancePanel created an event

SEMINAR

MAR

05

9:00 AM

Clinical Drug Development and Approval Process - 2-day In-person Seminar

DoubleTree by Hilton Baltimore - BWI Airport, 890 Elkridge Landing Rd, Linthicum Heights, MD 21090, USA

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...

Clinical Drug Development
FDA
GlobalCompliancePanel created an event

SEMINAR

MAR

05

9:00 AM

The A to Z's of HIPAA Privacy, Security, and Breach Notification Rules

Hilton Garden Inn Phoenix Midtown, 4000 N Central Ave, Phoenix, AZ 85012, USA

Overview: This session is designed to provide intensive, two-day training in HIPAA compliance, including what's new in the regulations, what's changed recently, and what needs to be addressed for compliance by covered entities and business associates.  The session provides the background and details for any manager of healthcare information privacy and security to know what are the most important privacy and security issues, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate.  Audits and enforcement will be explained, as well as privacy and...

GlobalCompliancePanel created an event

SEMINAR

JAN

22

9:00 AM

2-day In-person Seminar on Basics of US Medical Device Regulation at SFO, CA

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Overview: ·         Break Overnight ·         Clinical Trials o    IDE o    Other o    Export for trials o    Common problems in trial design and management ·         Post marketing o    QSR o    CAPA o    Reporting o    Inspections o    Export for foreign markets ·         Pop quiz o    Give quiz o    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 preparing the product for US...

Compliance Solutions
Medical Device Training
FDA Regulations Training
Regulatory Training
Food Safftey Trainig
Aerospace Compliance
Air Traffic Control
GlobalCompliancePanel created an event

SEMINAR

DEC

04

8:30 AM

2-day In-person Seminar on 2014 Complete 1099, 1042-S and FATCA Year-End Update at Los Angeles, CA

DoubleTree by Hilton Hotel Los Angeles Downtown, 120 N Los Angeles St, Los Angeles, CA 90012, USA

Overview: We will share the regulatory compliance issues and best practices for collecting Forms W-9 and W-8, performing TIN matching, your information reporting requirements, if and when back-up withholding must begin and the withholding rates, efficient handling of CP-2100 / B-Notices, responding to IRS notices of proposed penalties, reporting to non-resident aliens, and compliance with the Foreign Account Tax Compliance Act (FATCA). Why should you attend? In addition, how do you determine whether you can accept a W-9 from someone or you must request a W-8 instead? What if you send them...

Foreign Account Tax Compliance Act
Banking and Finance
Banking and Finance Regulations
Compliance Training
Regulatory Training
Aerospace (AS9100 Products)
Finance and Banking
GlobalCompliancePanel created an event

CONFERENCE

NOV

13

9:00 AM

Seminar on Validation and Part 11 Compliance of Computerized Analytical Systems at Singapore

Mandarin Orchard Singapore, 333 Orchard Rd, Singapore 238867

Course "Validation and Part 11/Annex11 Compliance of Computerized Analytical Systems and Data" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. 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...

Compliance Training
Regulatory Training
FDA Training
Regulatory Compliance Training
FDA Compliance
SOX Compliance Training
FDA Compliance Training
GlobalCompliancePanel created an event

SEMINAR

OCT

09

9:00 AM

The DHF, Technical File and Design Dossier - Similarities, Differences and the Future

Hilton Grand Vacations Suites at the Flamingo, Las Vegas, NV, USA

Summary: 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 Learning Objectives: This seminar / workshop will examine the existing and proposed requirements for the U.S. FDA's DHF -- including its derivative documents, the DMR...

Compliance Training
EU’s Medical Device Directive
Device Master Record
Device History Record
GlobalCompliancePanel created an event

SEMINAR

SEP

29

9:00 AM

Effective Complaint Handling, Medical Device Reporting and Recalls

Hilton Zurich Airport, Hohenbühlstrasse 10, 8152 Opfikon, Switzerland

2-day In-person Seminar on “Effective Complaint Handling, Medical Device Reporting and Recalls and Avoiding Costly Errors” in Switzerland from GlobalCompliancePanel Detailed Description: An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analysed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of...

Compliance Training
FDA Training
Medical Device Handling
Legal
Procurement and Supply Chain
Production, Operations and R and D
GlobalCompliancePanel created an event

SEMINAR

SEP

25

9:00 AM

Effective Complaint Handling, Medical Device Reporting and Recalls in Australia

Hilton Sydney Hotel, 488 George St, Sydney NSW 2000, Australia

  Detailed Description: Discription: An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analysed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of...

Medical Devices
Compliance
FDA
Legal
Production, Operations and R and D
GlobalCompliancePanel created an event

SEMINAR

SEP

11

9:00 AM

GMP Compliance for Pharmaceutical Quality Control Laboratories in Melbourne

, Melbourne VIC, Australia

Overview: This course is designed for people who are growing in their knowledge of pharmaceutical quality control practices and regulations. It will be a "how to" course where the instructor will explain the reasoning as well as the procedures that should be used to meet the various requirements of the pharmaceutical QC laboratory. The instructor will present different areas of work with a "how to" approach so that the seminar participant can see how the subject matter applies to the participant's work either now or in the future. In addition to discussing the particular subjects he will...

GMP Compliance
Quality Control Laboratories
Pharmaceutical
Good Manufacturing Practice
GMP training
Compliance Training
Risk management
GlobalCompliancePanel created an event

SEMINAR

SEP

04

9:00 AM

2-day In-person Seminar on Global Medical Device Regulation: US, EU and Canada at Chicago IL

Courtyard Chicago O'Hare, 2950 S River Rd, Des Plaines, IL 60018, USA

Overview: This course provides an overview of international medical device regulations. Beginning with a discussion of the similarity of global requirements, including both voluntary and mandatory standards and directives, and progressing to in-depth analyses of market specific requirements, the course provides the student with resources to meet the regulatory requirements for the largest world markets. Country-specific regulatory requirements for Canada, EU, and US are included. Why should you attend? This course provides a basic description of global regulatory strategy for medical...

Compliace
Compliance Training
Global Medical Device Regulation
Medical Device Regulation
Medical Device Training
FDA Medical Device
GlobalCompliancePanel created an event

SEMINAR

SEP

04

9:00 AM

Advertising and Promotional Requirements for Drugs and Medical Devices

Courtyard Chicago O'Hare, 2950 S River Rd, Des Plaines, IL 60018, USA

Overview: The changing game for drug and device marketing, however, is governed by antiquated and inadequate rules created for traditional print and broadcast advertising by the Food and Drug Administration ("FDA"). How the FDA will deal with such advanced communication technology that can go "viral" and just as quickly disappear is the question that the industry is eager to have answered. The FDA regulates the promotion of prescription drugs, biologics, medical devices and biotechnology products to ensure that the information is not false or misleading. The FDA has for decades regulated...

Compliance training
FDA
Medical Devices
Promotion of Drugs
GlobalCompliancePanel created an event

SEMINAR

AUG

14

8:30 AM

Applying ISO14971:2012 and IEC62304 - A Guide to Practical Risk Management

Hilton Zurich Airport, Hohenbühlstrasse 10, 8152 Opfikon, Switzerland

Overview: Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the...

Medical Devices
Risk Management
ISO14971
ISO 14971 Risk Management
Medical Device Software
Production, Operations and R and D
GlobalCompliancePanel created an event

SEMINAR

AUG

07

8:30 AM

FDA Based Guidelines on Statistical Sampling Plans

Mandarin Orchard Singapore, 333 Orchard Rd, Singapore 238867

Overview: Statistical tools and techniques are very commonly used to help measure and improve the quality of a firm's process and product. If statistical analysis is not properly performed and/or understood, a firm can run the risk of distributing the kind of product to the market that ultimately fails, resulting in lost time and money. And of course, with statistics, practice makes perfect. During this two-day HIGHLY interactive training program, participants will be given the opportunity to apply statistics learned to real-world example data sets! The program begins by...

FDA Based Guidelines
Medical Device
FDA
FDA regulations
Management
Production, Operations and R and D
GlobalCompliancePanel created an event

CONFERENCE

AUG

04

8:30 AM

Statistical Considerations for ICH Guidelines

Hilton Sydney, 488 George St, Sydney NSW 2000, Australia

Overview: This unique hands-on course will provide attendees with an understanding of how to apply to Statistics to the ten ICH Quality guidelines. The course will deliver tools, templates and insight that will allow participants to immediately begin implementation within their organization/firm. How well do you understand how you can utilize statistics to address the ICH guidelines? Most organizations have programs and procedures but fall short in the implementation of the tool and techniques used to apply the appropriate statistical tools. This 2 day hands-on workshop explores the unique...

ICH Guidelines
ICH Data and Statistics
pharmaceutical
GlobalCompliancePanel created an event

CONFERENCE

FEB

20

9:00 AM

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

Courtyard San Francisco Airport, 1050 Bayhill Drive, San Bruno, California 94066, USA

Title: 2-day In-person Seminar on “Regulatory Compliance for Dietary Supplements in the US, EU and Canada” in San FranciscoDescription: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 you should attend:In order to successfully market dietary supplements in the U.S. and Canada, it's essential to understand and implement regulatory requirements for these regions. This 2 day...

GlobalCompliancePanel created an event

CONFERENCE

FEB

13

9:00 AM

Pharmaceutical Water Systems

Courtyard Washington Capitol Hill/Navy Yard, 140 L Street Southeast, Washington, DC, United States

2-day In-person Seminar on “The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems” in Washington DC   Description: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 systems. The instructor will provide the necessary...

GlobalCompliancePanel created an event

SEMINAR

FEB

06

9:00 AM

Computer System Validation : 2-day In-person Seminar

Courtyard Chicago Downtown/River North, 30 West Hubbard Street, Chicago, IL, United States

2-day In-person Seminar on “Computer System Validation - Reduce Costs and Avoid 483s” at Chicago ILDescription:Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. The latter impact all areas of ICH Q9 and ICH Q10. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business...

GlobalCompliancePanel created an event

SEMINAR

FEB

03

9:00 AM

Pharmaceutical Water Systems in Saudi Arabia : 2-day In-person Seminar

Hilton Garden Inn Riyadh Olaya, PO Box 15553, Riyadh - Olaya, 11454, Saudi Arabia

2-day In-person Seminar on “The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems” in Saudi ArabiaDescription: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 systems. The instructor will provide the necessary background needed to...

Healthcare
Compliance
Medical