ComplianceOnline

Product Risk Management File Case Study

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

recorded version

$299.00
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

$500.00
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

Customer Care

Fax: +1-650-963-2556

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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.

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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