An overview of FDA’s medical device Quality System Regulation, 21 CFR Part 820.
FDA’s medical device Quality System Regulation, 21 CFR Part 820, includes requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices intended for human use. This webinar will address these matters.
Attendees will learn FDA’s expectations for the implementation and on-going operation of an effective medical device quality system.
- Regulatory basis
- Quality System
- Design Controls
- Document Controls
- Purchasing Controls
- Identification & Traceability
- Production & Process Controls
- Acceptance Activities
- Non-conforming Product
- Corrective & Preventive Action
- Labelling & Packaging Control
- Handling, Storage, Distribution, & Installation
- Statistical Techniques
Who Will Benefit
- Medical device company personnel working in production
- Regulatory Affairs
Faculty Paul Larocque
President at Acerna Inc.
Greater Toronto Area, Canada
Paul Larocque is the President of Acerna Inc., a pharmaceutical, biological, and medical device consultancy, which provides good manufacturing practice and regulatory affairs services to a global clientele. For the past years consulting, and previously in industry, Paul’s focus was FDA compliance matters.
Previously, Paul held executive positions with Pfizer, Allergan, and Teva Pharmaceuticals, all related to sterile products. He was also head of the unit responsible for the review of the chemistry and manufacturing parts of drug submissions at Health Canada. He also chaired the industry committee that negotiated the sterile products chapter of the GMP regulations at Health Canada. He has provided expert sworn testimony in various legal cases.