In this webinar attendees will learn both the U.S. FDA and EU's MDD/MDR expect documented risk-based "master" and "individual" V&V planning. Various validation terms are explained with useable “working” definitions. The Validation Master Plan, and suggested field-tested individual V&V plans, Test Report / Protocol formats, and individual test cases, IQ, OQ, and PQs, are presented.
FDA Warning Letters and recalls indicate major cGMP deficiencies in device and pharma companies on both sides of the Atlantic. One major failing is lack of sufficient or targeted risk-based V&V planning. And confusion over what the term "risk-based really means. Aa review of Internet forums shows confusion as to what is risk and what is V&V planning. What is the VMP and the individual V&V plan and there formats and roles. What are the "must have" elements from ISO 14971 and ICH Q9 for hazard analysis and product risk management? How can these be integrated? Mandatory risk for Software / firmware V&V.
This webinar will review company's Validation Master Plan for major cGMP deficiencies. Review hazard and risk management tools per ISO 14971 and ICH Q9. Utilize sufficient or targeted risk-based V&V planning. Use the VMP and Product Risk Management Files to develop meaningful product and process validations. Address "worst case allowables". 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. The models presented simplify "as-product", in-product", process and equipment, software VT&V, assuring key FDA requirements are not overlooked. V&V of a company's QMS and 21 CFR Part 11 are considered.
Areas Covered in the Webinar:
John E LincolnPrincipal, J E Lincoln and Associates
John E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company with over 31 years’ experience in U.S. FDA-regulated industries, and 17 years as a full-time consultant. Mr. Lincoln 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, and technical files. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D). In addition, Mr. Lincoln has prior experience in military, government, electronics, and aerospace. He has published 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. Mr. Lincoln is a graduate of UCLA.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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