ComplianceOnline

Product Risk Management under FDA and ISO 14971:2007

Instructor: John E Lincoln
Product ID: 701176
  • Duration: 60 Min

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

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This Product risk management training/webinar for Medical devices will help in to develop a compliant Hazard Analysis / Risk Management File and Report, as outlined in the newly revised ISO 14971:2007.

Description

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 the newly revised 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:

  • 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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