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FDA’s QMSR is Coming: Practical Readiness for Quality Teams

FDA’s QMSR is Coming: Practical Readiness for Quality Teams

Overview: With the FDA’s Quality Management System Regulation (QMSR) taking effect in February..

Date : 21st January 2026

Time : This Event is Over and the Recorded Content is Available

Duration : 60 Mins

Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA in 2025

Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA in 2025

Overview: The U.S. Food and Drug Administration (FDA) plays a critical role in safeguarding pub..

Date : 27th June 2025

Time : This Event is Over and the Recorded Content is Available

Duration : 90 Mins

Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA in 2024

Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA in 2024

Overview: The U.S. Food and Drug Administration (FDA) plays a critical role in safeguarding p..

Date : 30th August 2024

Time : This Event is Over and the Recorded Content is Available

Duration : 90 Mins

Free Webinar - FDA Warning Letter on AI Reliance: CGMP Documentation, Quality Unit Review, and Human Accountability

Free Webinar - FDA Warning Letter on AI Reliance: CGMP Documentation, Quality Unit Review, and Human Accountability

Scroll to the bottom to watch the entire 30 mins explainerOverview Artificial intelligence is ..

Date : June 2026

Time : N/A

Duration : 30 Mins

Medical Device Hazard Analysis Under FDA QMSR: A Practical ISO 14971 Guide

Medical Device Hazard Analysis Under FDA QMSR: A Practical ISO 14971 Guide

OverviewHazard analysis has always played an important role in medical device safety. Under FDA’s ..

Date : 25th August 2026

Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time

Duration : 75 Mins

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