Overview:
This course will explain the new FDA QMSR that goes into effect in February 2026.
The integration of ISO 13485 into 21 CFR Part 820 to form the QMSR will be explained. The QMSR isn’t a revision. It changes the approach to a QS. It aligns FDA requirements with ISO 13485 while retaining many of the FDA QSR requirements. Emphasis is on applying risk to the processes of the QS. Compliance is more than creating documents , it is process oriented analysis
An important part of the QMSR is applying risk evaluation to QS processes. However, it does not describe how to do this. We will explain the Hazard Analysis process, following ISO 14971, and how to apply it to the QS processes.
Top management must now be very involved in the QS. We will describe the new FDA expectations for top management.
Supplier oversight is strengthened.
Inspections now not only examine product quality, but include the QS. A deficient QS can result in inspection failure.
Why you should Attend:
Device manufacturers will face new and stricter requirements than before. The emphasis is on controlling quality of the processes involved in the Quality System. Creating documents that prove product quality is not sufficient. Quality is no longer documents. Quality is the process that controls the documents. Conforming to ISO 13485 is not sufficient. Having risk based quality processes is necessary. These processes include supplier control, CAPA, change control, and training. FDA inspections will include the quality system and a deficient QS may result in inspection failure.
Handouts are pre release change control form, post release change control form.
Areas Covered in the Session:
- ISO 13485
- QMSR requirements
- Retained sections of 21 CFR 820
- Hazard analysis procedure
- How to apply risk analysis to QS processes
- FDA inspections
Who Will Benefit:
- Engineering personnel
- Software developers
- Development Engineers
- Production Management
- QA/ QC personnel
- Management