Software Verification and Validation For FDA-Regulated Industries

Instructor: John E Lincoln
Product ID: 701135
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

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This FDA compliance training will guide you through Software Verification and Validation process in FDA-Regulated Industries.


U.S. FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based software V&V. 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.

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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Product Reviews Write review

Powerpoint presentation was nice.
- Anonymous

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