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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

An Advanced Course on Lean Documents, Lean Configuration, and Document Control - What to Know

An Advanced Course on Lean Documents, Lean Configuration, and Document Control - What to Know

Overview: In today’s life sciences environment, document control is often where “lean” quietl..

Date : 26th January 2026

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

Duration : 90 Mins

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

Medical Device Cybersecurity Following FDA’s 2026 Premarket Guidance

Medical Device Cybersecurity Following FDA’s 2026 Premarket Guidance

Overview Cybersecurity is now a central part of FDA’s review expectations for many connected, ..

Date : 28th May 2026

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

Duration : 75 Mins

Best Practices for FDA Computer System Audit Preparation in 2026

Best Practices for FDA Computer System Audit Preparation in 2026

Overview: For those of us who have worked around FDA-regulated computer systems for many year..

Date : 29th May 2026

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

Duration : 90 Mins

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