The recent high-profile recalls and FDA Warning Letters indicates that big cGMP deficiencies in big name device and pharma companies. At present the FDA is taking even a tougher stance. Lack of enough or targeted risk-based process Verification and Validation (V&V) planning/execution is one major failing and FDA’s target area. Pharma and device companies must consider various FDA Validation Guidance Documents and their "must have" elements, as well as ISO 14971 (devices) and ICH Q9 (pharma) for hazard analysis and product/process risk management incorporation.
Integration of product and process validation is essential to a company's quality management system. Effective and real world V&V is even more important in today’s resource constrained industrial environment. This session by expert speaker John E. Lincoln will focus on field proven U.S. FDA documentation "models" in various applications, including devices, production/test/LIM equipment, ERP, process V&V, and 21 CFR Part 11 (electronic records/signatures) -- wherever cGMP data/records are gathered, utilized, stored and retrieved.
Validation Master Planning (VMP) or (MVP) is not specifically referenced in any CGMPs. But it’s a requirement and reviewed during FDA and ISO OMS CGMP compliance Audits. One of the major drawback is the lack of proper or targeted risk-based V&V planning and related documentation. Starting with the Master Validation Plan, evaluating its elements against ICH Q9 and ISO 14971 for product risk management and hazard analysis, permits the development of meaningful product quality-specific process validations.
Why Should You Attend:
After attending this webinar you will be equipped in developing a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management for development of meaningful product validations. You will also learn key success factors for risk-based V&V planning to meet FDA and ISO 13485 requirements
You will also get answers to the following tough questions:
Who Should Attend
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
- Dr. David Lim
John E. Lincoln is the Principal of J. E. Lincoln and Associates LLC, a consulting company; with over 35 years of experience in U.S. FDA-regulated industries, 21 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...
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