ISO 14971:2007 -- The Newly Revised Risk Management Standard for Medical Products

The US FDA is increasingly stating that many regulated activities should be “risk-based”. Major resource-consuming activities such as product and process / equipment / facility, and software validation, CAPA investigations, vendor audits can all be tailored to a risk based approach This eliminates the current SOP-defined “one size fits all” approach, to a flexible, resource adjusted approach, less arbitrarily defined in an SOP, but yielding results targeted to real needs. Attendees will be helped to see how to develop a compliant Hazard Analysis / Risk Management File and Report, as outlined in ISO 14971:2007, a standard recognized by the FDA and rapidly being adopted by industry. Then how to use this document to accomplish the above goals.

Areas Covered in the seminar:

• An overview of the new ISO 14971:2007 standard with emphasis on changes from the 2001 version.
• The Hazard Analysis and its source material.
• Use of the Appendices.
• Concept of risk evaluation, control, reduction.
• Risk management tools -- FTA, FMECA.
• Residual risk.
• Risk / benefit analysis.
• The Risk Management Plan, File and Report.

Who Will Benefit:

This webinar will provide valuable information to all regulated companies that are developing, maintaining and updating their products' Risk Management Files / Reports. All regulatory activities have as risk-base approach, and compliance with risk management standards form the basis for using this approach. A risk based approach can best utilize limited resources for maximum impact in key activities such as CAPA, validation and verification, root cause / failure investigations, and similar. It offers an alternative to a "one size fits all" approach, most often used to ill effect in many companies.

• For employees and management in the Medical Device, Pharmaceutical, Diagnostic, and Biologics industries
• R&D
• Engineering
• Sales and Marketing
• Consultants
• QA/ RA/ QAE

Instructor Profile:

John E Lincoln, consultant, has successfully designed and implemented complete 21 CFR 210, 211, 820 and ISO 13485 quality management systems, which have passed FDA audits, and described in peer-reviewed technical articles and workshops, world wide. John has managed pilot production, regulatory affairs, product development, and quality audits. He has over 25 years of experience, primarily with medical devices – 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, the Journal of cGMP Compliance, Intermountain Biomed- ical Association, and publishes a newsletter. He is a graduate of UCLA.

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