The FDA QMSR and the Key Elements of QSIT cGMP Inspection and Audits for Medical Device Manufacturers
Mon, 17 Nov
|Virtual Event
Faculty: John E. Lincoln | November 17 - 18, 2025 US Eastern Time: 10 AM to 3 PM | Central Europe Time: 4 PM to 9 PM
Time & Location
17 Nov 2025, 10:00 am GMT-5 – 18 Nov 2025, 3:00 pm GMT-5
Virtual Event
About the event
Description
What are U.S. FDA cGMP requirements for the manufacture of medical devices for sale in the US? Discuss the key Quality System Regulation / Quality Management System requirements of 21 CFR 820, the Quality System Regulation. QSIT for FDA inspections. And anticipated changes to a QMSR.
This 2-day seminar will examine the 14 key elements of the Medical Device cGMPs, 21 CFR 820, the Quality System Regulation, the 7 key elements, and the defining 4 elements, as defined and evaluated by the FDA's QSIT. Product development and manufacturing ("realization") and its compliance and documentation. Design Control, the Device History File, the Device Master Record and the Device History Record are defined. Corrective and Preventive Action (CAPA) requirements and key components. Production and Process Control (P&PC) expectations. Verification and Validation, including software - Why and How? Risk management under ISO 14971, a major component of the proposed QMSR, will also…