Validation Planning to Meet US FDA and ISO 13485 Requirements

Instructor: John E Lincoln
Product ID: 701206
  • Duration: 60 Min

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


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This FDA validation training will guide you through the validation planning which required meeting the US FDA & ISO 13485 Requirements.


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 V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. Also: 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, budgets, time). A matrix simplifies “as-product”, “in-product”, process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 are considered.

Areas Covered in the seminar:

  • Verification or Validation -- Recent regulatory expectations.
  • The Master Validation Plan.
  • Product Validation – how it differs from Process / Equipment V&V.
  • Process / Equipment / Facility Validation.
  • When and How to use DQ, IQ, OQ, PQ.
  • How to use your Risk Management Tools (per ISO 14971) – expand or contract the validation templates.
  • The 11 “must have” elements of software validation.
  • “White box” and/or “black box” and some test case suggestions.

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 company-wide V&V planning, using a 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 and run all types of qualifications / validations, which have passed FDA audit or submission review, and have been 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 28 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, the Journal of cGMP Compliance, and past training chair - Intermountain Biomedical Association), and publishes a newsletter. He is a graduate of UCLA.

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