Review a company's Test Method and Design 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 and associated documentation. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 for hazard analysis and product risk management, allows the development of meaningful product quality-specific process validations, especially at the design stage (820.30). Also the roles of different V&V protocols; how to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents. Our matrix examples simplify "as-product", in-product", process and equipment, et al, software VT&V, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 and cybersecurity are considered where required.
Why Should You Attend:
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in test method / device design verification and validations. What are the regulatory requirements? One major failing is lack of sufficient or targeted risk-based process V&V planning / execution. The "must have" elements from ISO 14971 for hazard analysis and product / process risk management. Integration of test method validation essentials into a company's quality management system, specifically its design control activities.
Areas Covered in the Webinar:
Participants will learn how an effective Test Method Validation system is a critical requirement to the movement toward a risk-based approach to compliance and product safety.
Issues to be covered include:
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies that need to review and modify their Test Method / Device Design Validation Planning and Execution / Documentation. While this information is focused on Medical Devices, many of its principles apply to personnel / companies in the Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include:
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 41 years experience in U.S. FDA-regulated industries, 27 years as head of his own consulting company. 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, 5 chapters in the RAPS textbook on validation, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of UCLA.
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