Pack of two courses: The essentials of Food and Drug Administration Medical Device Regulations: A primer for manufacturers and suppliers

In the United States, the US Food and Drug Administrates Medical Devices through several different regulations, the principle one is the Quality System Regulation 21 CFR 820 (QSR). Other regulations include Registration and Listing, Labeling, Medical Device Reporting, and Corrections and Removals (Recalls). This 3-hour course pack will give an overview of all the major responsibilities for those who design, manufacture and distribute medical devices.

All Modules:

Module 1: The Essentials of Food and Drug Administration Medical Device Regulations: A Primer for Manufacturers and Suppliers; Part 1- Quality System Regulation
Module 2: The Essentials of Food and Drug Administration Medical Device Regulations: A Primer for Manufacturers and Suppliers; Part 2- Registration, Medical Device Reporting, Corrections and Removals (Recalls)

Module 1 : The Essentials of Food and Drug Administration Medical Device Regulations: A Primer for Manufacturers and Suppliers; Part 1- Quality System Regulation
Instructor: Edwin L. Bills

Area Covered:

• This session will identify who is responsible under the Quality System Regulation.
• Identify the responsibilities of Suppliers to Medical Device Manufacturers.
• Limits of the Design Control Regulation.
• What is Validation? Includes Process, Design and Software Validation.
• Preparing for Inspection.

Module 2 : The Essentials of Food and Drug Administration Medical Device Regulations: A Primer for Manufacturers and Suppliers; Part 2- Registration, Medical Device Reporting, Corrections and Removals (Recalls)
Instructor: Edwin L. Bills

Area Covered:

• This session will cover the responsibilities of the manufacturer for the regulations not covered in Part 1, Registration and Listing, Labeling, Medical Device Reports and Corrections and Removals (Recalls).
• What are the additional responsibilities of the Medical Device Manufacturer?
• What is Labeling-what about websites and videos?
• Do I really have to report adverse events in multiple countries?
• What field actions require reporting to the FDA?

Instructor Profile:

Edwin L. Bills , was a Quality and Regulatory Affairs Director at an international medical device manufacturer for 5 years after serving in a variety of positions with increasing responsibility in the medical device industry, including Supplier Quality Engineer and Manager, Quality Systems and Regulatory Affairs Manager, Product Risk Manager, and Director of North American Service Quality. He is Regulatory Affairs Certified by RAPS, and also a Certified Quality Engineer, Certified Quality Auditor, and Certified Manager of Quality/ Organizational Excellence by ASQ and is an ASQ Senior Member.

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