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

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

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Last Recorded Date: Mar-2008

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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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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

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