Product Risk Management - ISO 14971:2007
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This webinar will address the use of the ISO 14971 model to perform and document such activities and the additional actions necessary to make it a useful product reference and training tool.
The U.S. FDA has stated that the use of a medical device entails some degree of risk.Â In fact, any medical procedure / intervention does.Â 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.Â ISO 14971 provides an accepted vehicle by which to perform and document such an analysis and is accepted by the FDA.Â These activities can also be used as a method to train new hires, especially in Marketing, QA/RA, Engineering, and Manufacturing.
Areas Covered in the Session:
Who Will Benefit:
- The Revised ISO 14971:2007
- Product Hazard Analysis
- Design, Process, and Use[r] Failure Mode, Effects and Criticality Analysis
- Fault Tree Analysis
- The Team and It's Involvement â€“ Who, When and How
- Product Risk Management File and Report
- Using the Completed Document â€“ Itâ€™s Real Value
- Keeping it "In the Loop"
- A "Living Document"
- Senior Management, Project Leaders
- Internal / External Auditors and/or Consultants
- Regulatory Affairs
- Quality Systems Personnel / QAE
- New Product Development, Marketing and R&D
- Product and Process / Manufacturing Engineering Staff
- Document Control
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.
John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.