Product Risk Management under FDA and ISO 14971:2007

Areas Covered in the seminar:

• Elements of the revised ISO 14971:2007. Narrative, hazard analysis and the Appendices, risk analysis tools and rankings, the Risk Management File and Report;
• Changes from the previous version;
• Locating and using sources of hazards / risks;
• Parallel approaches to developing the document;
• When to involve teams;
• Who to consider for sign-offs / approvals;
• The Real Value: How to use the completed document;
• Ensure it remains a “living (and useful) document”.

Who will benefit:

• Senior management, project leaders
• Regulatory affairs
• Quality systems personnel:FDA and ISO / MDD / CE-marking compliance
• R&D and engineering staff
• All charged with new product development, regulatory submissions, initiating / overseeing product hazard analysis and remediation.
• CAPA and P&PC personnel desiring to reduce or redirect investigation and validation costs without sacrificing product safety and/or warranty costs.

Instructor Profile:

John E. Lincoln, consultant, has successfully designed, written over 50 ISO 14971-compliant Risk Management Files / Reports, including FMECA and FTA analysis, many in response to FDA 483 observation, which have subsequently 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 projects; with over 24 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.

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