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Validity : 30th Nov'21 to 10th Dec'21
Review a company's Verification and Validation System for major cGMP deficiencies. Address the FDA's newer and tougher regulatory stance. One major failing is 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. Also the role of the individual V&V plan, and different protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents, against a background of limited company resources. Sample test cases. A matrix simplifies "as-product", in-product", process and equipment,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 master V&V system, field-tested over decades, for all regulated industries, and US FDA CGMP and EU compliant.
This is one of our most requested webinars. FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in regulated companies. One major failing is lack of sufficient or targeted master verificatioin and validation planning and execution.But a review of Internet forums shows confusion as to what is V&V planning. What really is a Master Validation Plan? Why do companies need one? What is the individual V&V plan and its high value. What are 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? How can these be integrated?
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.