Preparing for the New FDA Medical Device Inspection Process - Webinar
Wed, 25 Feb
|Virtual Event
FDA inspections have changed, and QSIT is no longer the model. Join this webinar to understand how the new risk-based FDA inspection process works, and how to prepare your QMS and teams for what inspectors will actually look for.
Time & Location
25 Feb 2026, 2:00 pm – 3:00 pm GMT+2
Virtual Event
About the event
As of February 2026, the FDA has implemented a fundamentally updated inspection approach for medical device manufacturers, replacing the traditional QSIT model with a risk-based, total product lifecycle focused inspection program, Compliance Program 7382.850.
This webinar is designed for Quality and Regulatory professionals who want to clearly understand how FDA inspections are now conducted, what inspectors will focus on, and how this change impacts inspection readiness, inspection behavior, and post-inspection outcomes.
During the session, we will break down the new FDA inspection framework in practical terms, including:
How the FDA applies risk-based inspection models across QMS areas
What has changed in inspection scope, depth, and flow compared to QSIT
How inspectors use risk management, postmarket data, and quality signals to drive inspection paths
Tickets
General Free Ticket
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