QSR to QMSR: The Rewrite of 21 CFR Part 820 & Key Considerations for FDA Compliance
This on-demand webinar hosted by Greenlight Guru addresses the major transition from FDA’s Quality System Regulation (QSR) to a Quality Management System Regulation (QMSR), which will align with ISO 13485:2016, and a revision of relevant sections of 21 CFR Part 4 (Combination Products). Watch this session to learn about the QMSR proposed rule, next steps in the rulemaking and implementation process, and important considerations for medical device manufacturers. Main points covered: 1. Overview of the QMSR proposed rule and the transition from QSR. 2. Explanation of how ISO 13485 fits into the regulatory landscape. 3. Discussion of "incorporate by reference" in the context of these regulations. 4. Important concepts from the proposed rule. 5. The impact of QMSR on the industry and FDA. Target Audience: • Regulatory Affairs Professionals and Management • Quality Professionals and Management • Medical Device Executives Access the printable slides for this presentation here: https://www.greenlight.guru/webinar/q...
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