The Essentials of Food and Drug Administration Medical Device Regulations: A Primer for Manufacturers and Suppliers - Quality System Regulation
Instructor:
Edwin L Bills
Product ID: 700921
- Duration: 90 Min
Why Should You Attend:
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 program will introduce the Quality System Regulation which defines the responsibilities for those who design, manufacture and distribute medical devices.
Areas Covered in the seminar:
- 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.
Who will benefit:
This webinar is especially helpful for new startup companies that are entering the medical device field for the first time. It is also helpful for individuals that have not worked in the medical device field previously.
- Personnel new to the field should take both Part 1 and Part 2 sessions.
- Persons responsible for developing medical devices.
- Persons responsible for manufacturing medical devices.
- Persons responsible for purchasing components and services for medical device manufacturers.
- Persons responsible for quality systems, quality assurance and quality control.
- Persons responsible for servicing medical devices and for complaints.
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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