FDA's Guidance on Process Validation for Drugs and Biologics - 3 Steps to Compliance

Event Information
Product Format
Prerecorded Event
90 minutes
Product Description

Understand the 3 Step FDA Guidance on Process Validation for Drugs and Biologics


Recent high-profile recalls and FDA warning letters recall the major cGMP deficiencies in pharma organizations and big name device. Now, FDA is up to take a tougher stance. A single major failing is a clear indicator of lack of target-based/sufficient process V&V execution/planning. Now, you need to consider FDA’s Process validation guidance documents and the ‘must have’ elements in them. You need ICH Q9 for hazards analysis and product/process risk management incorporation, and also need to integrate process validation essentials into quality management system of a company. Effective and real world process V&V is even more important when it comes to today’s industrial environment that is extremely resource constrained.

Join expert speaker John E. Lincoln in this session, where he is going to focus on US FDA documentation models in various applications that are field proven – including, ERP, wherever CGMP data/records are collected, used, stored and retrieved, and process/equipment and test/lab equipment control. The session will:

  • Address the U.S. FDA's key January 2011 Process Validation Guidance Document
  • Provide 3 key steps to process lifetime compliance
  • Discuss the FDA’s newer and tougher regulatory stance on V&V requirements
  • Review a company's Process Verification and Validation system for major cGMP deficiencies

One major failing is lack of sufficient or targeted risk-based V&V planning and associated documentation. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management, allows the development of meaningful product quality-specific process validations. Also the 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. Our V&V “model” simplifies process and equipment, et al, hardware and software VT&V, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 are also considered.

Session Highlights:

  • The FDA’s Process V&V Guidance
  • Working toward homogeneity within and between batches – a key goal
  • The 3 Key / Lifecycle considerations
  • V&V Master Planning
  • Field-proven V&V “models” – useful for all V&V
  • Hardware and software V&V considerations
  • Developing test cases / scripts
  • “Risk Based”  -- what it means in V&V and how it should be used

Who Should Attend

  • Senior management in Drugs, Devices, Biologics, Combination products, Dietary Supplements
  • QA
  • RA
  • Engineering
  • R&D
  • Production
  • Operations
  • Consultants; others tasked with product, process, validations, CGMP responsibilities

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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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