Product Risk Management File Case Study

Instructor: John E Lincoln
Product ID: 700819
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

Attendees will be helped to see how to develop a compliant Hazard Analysis / Risk Management File and Report.


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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