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

Event Information
Product Format
Prerecorded Event
Conference Date
Tue, Aug 09, 2016
90 minutes
Product Description

Review Your Company’s Verification & Validation System for Major cGMP Deficiencies

The recent high-profile recalls and FDA Warning Letters indicates that big cGMP deficiencies in big name device and pharma companies. At present the FDA is taking even a tougher stance. Lack of enough or targeted risk-based process Verification and Validation (V&V) planning/execution is one major failing and FDA’s target area. Pharma and device companies must consider various FDA Validation Guidance Documents and their "must have" elements, as well as ISO 14971 (devices) and ICH Q9 (pharma) for hazard analysis and product/process risk management incorporation.

Integration of product and process validation is essential to a company's quality management system. Effective and real world V&V is even more important in today’s resource constrained industrial environment. This session by expert speaker John E. Lincoln will focus on field proven U.S. FDA documentation "models" in various applications, including devices, production/test/LIM equipment, ERP, process V&V, and 21 CFR Part 11 (electronic records/signatures) -- wherever cGMP data/records are gathered, utilized, stored and retrieved.

Validation Master Planning (VMP) or (MVP) is not specifically referenced in any CGMPs. But it’s a requirement and reviewed during FDA and ISO OMS CGMP compliance Audits. One of the major drawback is the lack of proper or targeted risk-based V&V planning and related documentation. Starting with the Master Validation Plan, evaluating its elements against ICH Q9 and ISO 14971 for product risk management and hazard analysis, permits the development of meaningful product quality-specific process validations.

Why Should You Attend:

After attending this webinar you will be equipped in developing a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management for development of meaningful product validations. You will also learn key success factors for risk-based V&V planning to meet FDA and ISO 13485 requirements

Session Highlights:

  • Review Validation Master Planning
  • FDA’s newer and tougher regulatory stance on Verification and Validation (V&V) requirements
  • Review your company's V&V system for major cGMP deficiencies
  • Roles of different V&V protocols
  • How to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents, against a background of limited company resources. 
  • A V&V “model” that simplifies process and equipment, et al, hardware and software VT&V, assuring key FDA requirements are not overlooked.
  • Review the QMS and 21 CFR Part 11
  • U.S FDA’s applicable V&V Guidance documents
  • V&V Master Planning
  • Individual V&V Plans
  • Addressing the “Worst Case” scenario
  • Hardware and software V&V considerations
  • Field-proven V&V “models” – useful for all V&V
  • Developing test cases / scripts
  • “Risk Based”  -- what it means in V&V and how it should be used

You will also get answers to the following tough questions:

  • How do you compile the Validation Master Plan?
  • Do you need to validate each piece of equipment separately if they are the same model?
  • Do I have to follow that FDA waterfall model for my product V&V?
  • Since the Requirements are the basis for V&V, how do I ensure they're complete?

Who Should Attend

  • Senior management in Drugs, Devices, Biologics, Combination products, Dietary Supplements
  • QA
  • RA
  • Engineering
  • Programmers
  • R&D
  • Production
  • Operations
  • Consultants; others tasked with product, process, validations, CGMP responsibilities
  • Useful for members of AQC, RAPS, AAMI, etc

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

John E. Lincoln

John E. Lincoln is the Principal of J. E. Lincoln and Associates LLC, a consulting company; with over 35 years of experience in U.S. FDA-regulated industries, 21 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation...   More Info
More Events By The Speaker

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