Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements

Instructor: John E Lincoln
Product ID: 700149
  • Duration: 60 Min

recorded version

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Training CD

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Developing a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management for development of meaningful product validations.


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.

Attend this seminar for learn key success factors for risk-based V&V planning to meet FDA and ISO 13485 requirements. It will cover creating a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, for development of meaningful product 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); developing 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 will also be discussed.

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)
  • The 11 "must have" elements of software validaiton
  • "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 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 Compliance, and Intermountain Biomedical Association), and publishs a newletter. He is a graduate of UCLA.

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Product Reviews Write review

Good seminar
- Anonymous

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