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Quality Management System Regulation (QMSR) – Replacement of QSR and Alignment with ISO

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

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

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

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

 Free Webinar - FDA QMSR Inspection Readiness: What Early Form 483 Observations May Reveal

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

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