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
Last Recorded Date: Mar-2009

Training CD / USB Drive

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

Customer Care

Fax: +1-650-362-2367


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.

Follow us :
Seminars by Ex-FDA Officials
Critical Vendor Risk Management

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email call +1-888-717-2436 (Toll Free).

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed