Risk-Based Software V&V - FDA,GAMP®, 14971

Instructor: John E Lincoln
Product ID: 700814
  • 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

This risk-based software V&V training will guide you through 11 "must have" elements of software validation and how to use your Risk Management Tools (per ISO 14971:2007).

One major failing is lack of sufficient or targeted risk-based software V&V planning. Starting with a Project Validation Plan, evaluating its elements against ISO 14971:2007 hazard analysis / risk management, allows development of meaningful product / process validations. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, against a background of limited company resources (personnel, budget, time). Two matrices / models simplify regulatory requirements for "as-product", "in-product", process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. QMS and 21 CFR Part 11 require yet another approach.

Areas Covered in the seminar:

  • Verification or Validation -- Recent Regulatory Expectations.
  • The Project Validation Plan.
  • Software Product Validation - how it differs from process / equipment V&V.
  • When and How to use DQ, IQ, OQ, PQ?
  • How to use your Risk Management Tools (per ISO 14971:2007)?
  • GAMP® guidance.
  • The 11 "must have" elements of software validation.
  • White box and/or "black box".
  • Some "real world" test case examples.

Who will benefit:

  • All Management Levels.
  • Project Leaders.
  • Regulatory Affairs.
  • Quality Systems Personnel.
  • R&D and Engineering Staff.
  • All charged with new product / pilot development, regulatory submissions, initiating / overseeing company-wide software / V&V planning, using an ISO 14971:2007-based risk-justified approach.
  • CAPA and P&PC personnel desiring to minimize post-production / life cycle and other costly problems.

NOTE: GAMP® is a registered trademark of ISPE. To learn more about GAMP®, visit

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.

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