GotoWebinar: Verification and Validation Planning and Execution – July 24, 1 PM EDT – Lincoln

GotoWebinar: Verification and Validation Planning and Execution – July 24, 1 PM EDT – Lincoln

April 22nd, 2019 // 9:06 pm @

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 company-wide 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. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, against a background of limited company resources (personnel, budget, 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 must be considered.

Subject areas covered

  • The Master Validation Plan and Structure
  • Working Definitions
  • Product Validation – how it differs from process and equipment V&V
  • Process/Equipment/Facility Validation – New FDA Guidance
  • When and how to use EQ, IQ, OQ, PQ or their equivalents
  • How to use product risk management tools per ISO 14971 and ICH Q9
  • The 11 key documents for software validation
  • Incorporating 21 CFR Part 11 requirements











Who should attend

Senior management in drugs, devices, biologics and dietary supplements

  • QA
  • RA
  • R&D
  • Engineering
  • Production
  • Operations
  • Consultants in product, process and software validation

About the Speaker

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 37 years experience in U.S. FDA-regulated industries, 23 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 and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files.  He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).  In addition, John has prior experience in military, government, electronics, and aerospace.  He has ptublished numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology.   John is a graduate of UCLA.












 


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