Review a company's Verification and Validation Program for major cGMP deficiencies. Address the FDA's newer and tougher regulatory stance. Address the lack of sufficient or targeted risk-based V&V planning. 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 and process validations, and eliminates omissions. The role of the individual V&V plan, and different protocols. How to employ equipment/process DQs, IQs, OQs, and PQs, or their equivalents, allowing for proper allocation of limited company resources. Sample test cases. A matrix simplifies "as-product", in-product", process and equipment, et al, FDA software V&V documentation requirements. The QMS and 21 CFR Part 11 validation requirements are considered. Formal ISO and CGMP definitions vs. “working definitions”. The end result of this webinar will be a format for a working corporate / distributed V&V program, field-tested over decades, for all regulated industries, and US FDA CGMP and EU compliant.
This is a variant of one of our most requested webinars. FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in regulated companies, much V&V related. This should be addressed by a corporate-wide verification and validation program. A review of Internet forums shows confusion as to what is V&V. What really is a Master Validation Plan? What are the individual V&V plan and its high value? What are the verification activities? Validation? Qualifications? IQ, OQ, PQs? Commissioning? FAT, SAT? How to translate Requirements into IQ, QO, and PQ test cases/scripts. What are the "must-have" elements from the US FDA’s CGMPs, ISO 13485, and other requirements that must be a driving part of such a program? How to ensure that they meet compliance and integration requirements while contributing to business success?
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 33 years experience in U.S. FDA-regulated industries, 19 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, CAPA systems and analysis. 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.