QMSR Is Coming: Preparing for the 2026 Shift in CGMP Requirements

December 10, 2025 | Live Webinar

Overview

Join our panel of experts to learn what FDA’s new QMSR final rule means for medical devices, in vitro diagnostics (IVDs), and combination products. Hear practical strategies to help your organization or your clients comply with the updated 21 C.F.R. 820 requirements—now aligned with ISO 13485:2016. Gain actionable tips to update internal procedures and minimize regulatory risk ahead of the February 2, 2026 FDA enforcement deadline.

$149

Members

$249

Non-Members

Speakers

Darin Oppenheimer
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Vice President Regulatory Affairs, Becton Dickinson

Benjamin K. Wolf
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Partner, Alston & Bird LLP

Moderated by Janet L. Michener Whipple
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Partner, ELIQUENT Life Sciences