Why Should You Attend:
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies. And now the FDA is taking an even tougher stance. One major failing is lack of sufficient or targeted risk-based process V&V planning / execution. Pharma companies must consider key elements of the FDA Process Validation Guidance Document; other medical products can use the same principles. Incorporate the "must have" elements from ISO 14971 and ICH Q9 for hazard analysis and product / process risk management. Then integrate all as process validation essentials and incorporate into a company's quality management system.
This webinar will review a company's process verification and validation system for major cGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. Attendees will learn how the FDA's recent process validation guidance for pharma can assist all regulated industries meet regulatory requirements. It will discuss how one can start with a Master Validation Plan, evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management, allows the development of meaningful product quality-specific process validations.
It will also discuss the roles of different V&V protocols; how to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents, against a background of limited company resources. The speaker will present a matrix that simplifies "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 will also be discussed briefly.
Areas Covered in the Webinar:
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies that need to review and modify their Process Validation Planning and Execution / Documentation. While this information is focused on Pharmaceutical and Medical Devices, its principles apply to personnel / companies in the Diagnostic, Combination, and Biologics fields as well. The employees who will benefit include:
John E. Lincoln, consultant, has successfully designed, written over 50 ISO 14971-compliant Risk Management Files / Reports, including FMECA and FTA analysis, many in response to FDA 483 observation, which have subsequently passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development / design control projects; with over 24 years of experience, primarily in the medical device industry – working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco / Mallinckrodt. John serves on the Reader and Editorial Review Boards of MDDI Magazine and the Journal of cGMP.
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