Hazard Analysis & Risk Management - New 14971

Instructor: John E Lincoln
Product ID: 700813
  • Duration: 90 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

Customer Care

Fax: +1-650-963-2556


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". 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 ISO 14971: 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?
  • How to use the completed document;Ways to ensure it remains a "living (and useful) document"?

Attendees for this 90-minute webinar will also receive a suggested Risk Management File template.

Who will benefit:

  • Senior Management.
  • Project Leaders.
  • Regulatory Affairs.
  • 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 developed and implemented and trained to device, pharma, medical gases, and dietary supplements CGMP-compliant systems. He has conducted compliance audits in all these areas. His systems have passed FDA audit or submission scrutiny, and have been described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development projects; with over 25 years of experience, in FDA-regulated 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); he publishes a newsletter. He is a graduate of UCLA.

ComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria.. Credit available for Live webinar Attendees only.

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