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Product Risk Management File Case Study
Attendees will be helped to see how to develop a compliant Hazard Analysis / Risk Management File and Report.
Description
The US FDA is increasingly stating that many regulated activities should be "risk-based". Proper "up-front" time spent in developing a realistic "real world" product Risk Management File and Report, can save the product development team time and wasted effort, minimize post-production surprises and recall / liability issues. Attendees will be helped to see how to develop a compliant Hazard Analysis / Risk Management File and Report, as outlined in the newly revised ISO 14971:2007, a standard recognized by the FDA and rapidly being adopted by industry. This will be accomplished by a Case Study of the step-by-step development of a product Risk Management File / Report. Then attendees will see how to use this document to realize practical results for their company and products.
Areas Covered in the seminar:
- The Basic Elements of ISO 14971:2007.
- Components of the Risk Management File and Report and their purposes.
- The Narrative, and suggested components.
- The Hazard Analysis and the 14971 Appendices.
- Locating and using sources of hazards / risks.
- Risk analysis tools (FTA, FMECA … ) and rankings.
- Parallel approaches to developing the document.
- When to involve teams.
- Who should make up the team; for sign-offs / approvals.
- Some uses for the completed document.
Who will benefit:
- Senior management, project leaders
- Regulatory affairs
- Quality systems personnel
- R&D and engineering staff
- All charged with new product development, regulatory submissions, initiating / overseeing product hazard analysis and remediation
- Actual or proposed members for a company's Product Risk Management Team
Instructor Profile:
John E. Lincoln, consultant, has successfully written or headed teams developing over 50 product / process risk management files/reports under ISO 14971:2001 and :2007, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, worldwide. John has also managed pilot production, regulatory affairs, product development / design control projects; with over 25 years of experience, primarily in the medical device industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco / Mallinckrodt. John serves on the Reader and Editorial Review Boards of MDDI Magazine and the Journal of cGMP Compliance, and Intermountain Biomedical Association), and publishes a newsletter. He is a graduate of UCLA.
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