FDA’s Proposed Changes to 21 CFR 820

by Michael B. Checketts published on November 10, 2023

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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