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Validity : 18th Dec'24 to 28th Dec'24
Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements
- Verification or Validation -- Current regulatory expectations.
- Purpose, format, contents, and execution of the Validation Master Plan and the Individual V&V Plans.
- When / how to use the DQ, IQ, OQ, PQ, or their ASTM E2500 equivalents.
- What is "risk-based"?
- Using the Risk Management tools of ISO 14971 and ICH Q9.
- The 11 Elements of the FDA’s software/firmware VT&V "Model".
- Part 11 and QMS software V&V.
- Key recent compliance problems and their resolution.
Overview of the webinar
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.
Who should attend?
- Senior and middle management.
- Quality Assurance
- Regulatory Affairs
- R&D
- Engineering, including software
- Sales and Marketing
- Operations / Production
Why should you attend?
FDA Warning Letters and recalls indicate major cGMP deficiencies in device and pharma companies on both sides of the Atlantic. One major failure is the lack of sufficient or targeted risk-based V&V planning. And confusion over what the term "risk-based really means. A review of Internet forums shows confusion as to what is risk and what is V&V planning. What are the VMP and the individual V&V plan and their 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 the 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 allowable". 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.
Faculty - Mr.John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 40 years experience in U.S. FDA-regulated industries, 27 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.