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Quality Management System Regulation (QMSR) – Replacement of QSR and Alignment with ISO
Overview: Effective February 2, 2026, FDA’s Quality Management System Regulation (QMSR) became..
Date : 23rd April 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Supplier Selection and Contract Manufacturer Qualification Under FDA QMSR
Overview: FDA’s QMSR places renewed emphasis on the way medical device companies evaluate, se..
Date : 24th March 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Prepare for FDA QMSR Inspections: 483 & Warning Letter Response
Overview: FDA inspections under the new QMSR can look and feel different—not just in what inv..
Date : 23rd February 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
ISO 13485:2016 Utilizing Principles of Lean Documents and Lean Configuration
Overview: Medical device and life science organizations are expected to maintain a Quality Ma..
Date : 20th February 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
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
Free Webinar - FDA QMSR Inspection Readiness: What Early Form 483 Observations May Reveal
Scroll to the bottom to watch the entire 20 mins explainerOverview: FDA’s Quality Manage..
Date : May 2026
Time : N/A
Duration : 20 Mins
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