GotoWebinar: Verification and Validation Planning and Execution – July 24, 1 PM EDT – Lincoln
April 22nd, 2019 // 9:06 pm @ jmpickett
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-productâ€, “in-productâ€, 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.
