Join Us: QMSR & What To Expect in 2026 | Warning Letter Wednesday
Join Us: QMSR & What To Expect in 2026 | Warning Letter Wednesday
January 30, 2026
Discuss this article with AI
Date: Wednesday, February 11, 2026
Time: 12:00 PM – 1:00 PM EST
Format: Online (Zoom)
Featured Speakers: Daniel Barreto, George Kwiecinski
Register Now
FDA's QMSR: Your Internal Audits Are Now Fair Game
The FDA's new Quality Management System Regulation (QMSR) takes effect February 2026, harmonizing 21 CFR 820 (view on KeyPedia) with ISO 13485:2016. Internal audit findings, management reviews, and corrective actions are no longer off-limits during FDA inspections.
Who's Leading This Session
Join Daniel Barreto and George Kwiecinski, two industry leaders in regulatory quality. Dan has guided dozens of companies through FDA inspection preparation, and George leads a company working on the cutting edge of tools supporting these initiatives.
New Year, New Playbook
With new regulations come new inspection attitudes and enforcement trends. The time to pressure-test your internal audit program, management review process, and CAPA loop is now, along with a reset in the methods and systems used.
Join Us
- Sign up for the February 11th webinar
- Read Dan's blog on QMSR and using KeyPedia for audit readiness
- Browse KeyPedia today
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