Overview
How to develop, modify and use hazard analysis and the Product Risk Management File and Report per ISO 14971:2019 and The New QMSR
Expectations for meaningful hazard analysis, hazardous conditions, and patient/ user risk documentation have always been required by regulatory agencies. And the new QMSR mandates it. There is an increased awareness of the importance of design activities to support the production of safe and effective product. Product risk management is a required tool to drive and direct resource constrained product design, manufacture and validation activities in the company. High-profile field problems indicate that such activities are not yet adequately planned, executed, and visibility maintained. There is a failure to fully utilize the power of current risk management tools. Effective use of such risk management tools can help address the growing push by the public and the FDA, to “toughen” its approach to product clearance and approval, while reducing liability issues. A suggested Field-tested and audited "model" format will be presented.
Why Should You Attend
The U.S. FDA has stated that the use of a medical device entails some degree of risk. In fact, any medical procedure / intervention does. A manufacturer is responsible to identify those risks, and take reasonable steps to mitigate them as far as practical and given the ‘state of the art’ at the time. ISO 14971 provides accepted methodologies by which to perform and document such an analysis and is accepted by the FDA. The new QMSR, referencing ISO 13485, empasizes risk management activities, as described in FDA's new Compliance Inspection Manual 7382.85 for QMSR, Feb 02, 2026. This webinar will address the procedures, provide and discuss suggested templates, necessary to develop or modify and then use the ISO 14971 models to perform and document such activities for any medical product. It will examine the additional actions necessary to make it a useful product reference, CAPA, root cause / failure investigation, and validation prioritization, and training tool, and how to maintain it as a “living document”. The latest change in ISO 14971:2019 will also be considered and discussed, including it's expansion to include a company's entire QMS
Webinar Takeaway
- The Current ISO 14971:2019 for Devices
- Risk is the Focus of Device FDA CGMP Inspections - FDA Manual 7380.850
- Product Hazard Analysis
- Design, Process, and Use[r] Failure Mode, Effects and Criticality Analysis
- Fault Tree Analysis
- Suggested Risk Management File / Review, FMECA, FTA Templates
- The Team and It’s Involvement – Who, When and How
- Using the Completed Document – It’s Real Value “In the Loop”
Who Will Benefit
- Senior management in Drugs, Devices, Biologics, Dietary Supplements
- QA
- RA
- R&D
- Engineering
- Production
- Operations
- Consultants; others tasked with project leadership responsibilities
Faculty John E. Lincoln
Medical Devices / Regulatory Consultant; also pharma and dietary supplements
Saint George, Utah
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.
