WEBINAR · ON-DEMAND
This webinar focuses on amendments to 21 CFR 820, which contains FDA requirements for Quality Management Systems. These regulations have existed since July 1978, and the FDA is now proposing changes to align more closely with QMS requirements used by other global regulatory authorities. The presentation familiarizes attendees with the proposed regulatory changes.
Key Takeaways
- Background on 21 CFR 820 and FDA Quality Management System requirements since 1978
- The FDA’s proposed amendments and their intent to align with global QMS standards
- How the proposed changes compare with QMS requirements used by other regulatory authorities
- What medical device manufacturers should prepare for as the changes take effect
Speakers
Michael Checketts
Omnex Consultant, Medical Device Quality & Regulatory Affairs
Michael Checketts brings 40+ years of experience in the medical device industry, having worked for both OEMs and first-tier suppliers. He has managed operations, engineering, and QA/RA functions for both startup and established manufacturers. As an Omnex consultant, he demonstrates expertise in ISO 9001, 13485, 14001, 14971, 17025, 62304, and 21 CFR 820, and the EU MDRs. He serves as an instructor and certified lead auditor across these regulatory frameworks.