# Join Us: QMSR & What To Expect in 2026 | Warning Letter Wednesday

Source: https://www.globalkeysolutions.net/media/qmsr-what-to-expect-2026-warning-letter-wednesday
Type: announcement
Published: January 30, 2026
Updated: March 12, 2026
Authors: Daniel Barreto, George Kwiecinski

> Join our free webinar on Feb 11 to learn how QMSR changes FDA inspections, internal audit scrutiny, and what quality teams must do to prepare for 2026.

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**Date:** Wednesday, February 11, 2026

**Time:** 12:00 PM – 1:00 PM EST

**Format:** Online (Zoom)

**Featured Speakers:** Daniel Barreto, George Kwiecinski

### [**Register Now**](https://lu.ma/4o80f2bz)

### FDA's QMSR: Your Internal Audits Are Now Fair Game

The [FDA's new Quality Management System Regulation (QMSR)](https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked) takes effect February 2026, harmonizing [21 CFR 820](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820) ([view on KeyPedia](https://www.globalkeysolutions.net)) with [ISO 13485:2016](https://www.iso.org/standard/59752.html). Internal audit findings, management reviews, and corrective actions are no longer off-limits during FDA inspections.

### Who's Leading This Session

Join [Daniel Barreto](https://www.linkedin.com/in/daniel-barreto-021827b4/) and [George Kwiecinski](https://www.linkedin.com/in/kwiecinskigeorge/), 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](https://www.globalkeysolutions.net/media/c7908633-f40a-4c9b-97f7-3623d2f0250d) loop is now, along with a reset in the methods and systems used.
### Join Us

- [**Sign up for the February 11th webinar**](https://lu.ma/4o80f2bz)
- [**Read Dan's blog on QMSR and using KeyPedia for audit readiness**](https://www.globalkeysolutions.net/media/qmsr-is-changing-what-good-audits-really-mean)
- [**Browse KeyPedia today**](https://www.globalkeysolutions.net/auth/signup)