Overview
Review a company's Test Method and Design Verification and Validation system for major systems: Test Methods, Equipment, Cleaning, Process and Sterilization V&V. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 / ICH Q9 for hazard analysis and product risk management, allows the development of science-based verifications and validations. Also the roles of different V&V protocols; how to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents. Part 11, cybersecurity and software VT&V are also addressed.
Why Should You Attend
FDA Warning Letters and recent high-profile recalls indicate deficiencies in verifications and validations of Analytical Test Methods, Process, Cleaning, Equipment and Sterilization Validations. What are the regulatory and documentation requirements? How does risk-based safety V&V planning / execution function and how documented per ISO 14971 and ICH Q9? Various Test Case formats and Test Report / Protocol examples are provided.
Webinar Takeaway
Participants will learn how an effective Verification and Validation plans/systems for test methods, equipment, process, cleaning, and sterilization are a critical requirement to the movement toward a risk-based approach to compliance and product safety.
Issues to be covered include:
- Equipment, process, cleaning, sterilization and test methods validations
- FDA V&V guidelines
- Basic GLP / CGMP requirements
- Understand the scope of regulations governing these key V&V areas
- Develop the various V&V test cases and Report formats for the key V&V areas discussed
- Learn how to construct, implement and deploy a Validation Master Plan
Who Will Benefit
This webinar will provide valuable assistance to all regulated companies that need to review and modify their Validation Planning and Execution / Documentation, meeting US FDA and EU MDR / EMA requirements. These principles apply to personnel / companies in theDevice, Pharmaceutical, Diagnostic, and Biologics fields and Combo products. The employees who will benefit include:
- Senior management
- R & D
- Quality Assurance / Regulatory Affairs
- Production
- Engineering, including Software
- All personnel involved in verification and/or validation planning, execution and documentation.
Faculty John E Lincoln
Principal, J E Lincoln and Associates
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 published 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.
