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