FDA’s Proposed Changes to 21 CFR 820
21 CFR 820 contains the FDA’s requirements for Quality Management Systems. These requirements have been around a long time (since Jul 1978). FDA is now proposing to amend this regulation to align more closely with QMS requirements used by other global regulatory authorities. The purpose of this presentation is to familiarize attendees with the proposed changes.
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Upcoming Webinar : Safe and Secure Development
Speakers:
Chad Kymal, Emil Pop, Juan Pimentel, Juan Webb, Nikhil Unnikrishnan, Serkan Bilecen
Date and Time:
Apr 2 2026 11:00AM Eastern Time (US and Canada)
RegisterUpcoming Webinar : Building Trustworthy, Well-Governed AI Systems: ISO/IEC 42001 from Risk to Readiness
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Date and Time:
Apr 7 2026 11:00AM Eastern Time (US and Canada)
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