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.

Watch the presentation to know more..

Upcoming Webinar : Update to ISO Standards – ISO 9000, ISO 9001, ISO 14001, and ISO 45001

Speakers:

Dan Reid, wkovacich@omnex.com

Date and Time:

Jun 20 2025 11:00AM Eastern Time (US and Canada)

Register

Upcoming Webinar : AI powered Requirements Management

Speakers:

Chad Kymal,Nikhil Unnikrishnan,John Stawarz

Date and Time:

Jun 26 2025 11:00AM Eastern Time (US and Canada)

Register

Related Training

Cybersecurity for Medical Devices

Internal Auditor Training Based on the International MDSAP Audit Approach

Understanding ISO 14971:2019 Application of Risk Management to Medical Devices

ISO 14971 Application of Risk Management to Medical Devices - PFMEA Overview

ISO 14971:2019 Application of Risk Management to Medical Devices Including DFMEA and PFMEA