Review a company's software and Part 11 Verification and Validation System for major cGMP deficiencies. Address the FDA's newer and tougher regulatory stance, and how it addresses Part 11. Evaluating its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management.The role of the individual V&V plan, and different protocols; how to employ IQs, OQs, and PQs, or their equivalents. Our matrix simplifies QMS / CGMP software / e-records / e-sigs VT&V, assuring key FDA requirements are not overlooked. Formal ISO and CGMP definitions vs. “working definitions”. The end result of this webinar will be a format for a working V&V system, and a Part 11 Test Report / Protocol format, field-tested over decades, for all regulated industries, and US FDA CGMP and EU compliant.
A review of Internet forums shows confusion as to what is 21 CFR Part 11, Electronic Records / Signatures, and how is it to be addressed. How are electronic CGMP records and/or signatures to be verified and validated? Should they? What are US FDA expectations? EU (Annex 11)? What are compliant companies now doing? How should such V&V documented? A “model”, accepted by regulatory agencies. What are appropriate 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 ISO 14971 and ICH Q9 for hazard analysis and product risk management? 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.