Compliance Trainings, Online
2016-04-27
Description : Recent high-profile recalls and FDA warning letters recall the major cGMP deficiencies in pharma organizations and big name device. Now, FDA is up to take a tougher stance. A single major failing is a clear indicator of lack of target-based/sufficient process V&V execution/planning. Now, you need to consider FDA’s Process validation guidance documents and the ‘must have’ elements in them. You need ICH Q9 for hazards analysis and product/process risk management incorporation, and also need to integrate process validation essentials into quality management system of a company. Effective and real world process V&V is even more important when it comes to today’s industrial environment that is extremely resource constrained. We will focus on US FDA documentation models in various applications that are field proven – including, ERP, wherever cGMP data/records are collected, used, stored and retrieved, and process/equipment and test/lab equipment control. The session will: Address the U.S. FDA's key January 2011 Process Validation Guidance Document Provide 3 key steps to process lifetime compliance Discuss the FDA’s newer and tougher regulatory stance on V&V requirements Review a company's Process Verification and Validation system for major cGMP deficiencies One major failing is lack of sufficient or targeted risk-based V&V planning and associated documentation. Starting with a Master Validation Plan, evaluating 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. Also 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. Our V&V “model” simplifies process and equipment, et al, hardware and software VT&V, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 are also considered. Areas Covered in the Session : The FDA’s Process V&V Guidance Working toward homogeneity within and between batches – a key goal The 3 Key / Lifecycle considerations V&V Master Planning Field-proven V&V “models” – useful for all V&V Hardware and software V&V considerations Developing test cases / scripts “Risk Based” -- what it means in V&V and how it should be used Who Will Benefit: This training applies to personnel / companies primarily in the pharmaceutical, devices, biologics and Combination Products fields. The employees who will benefit include: Senior management Quality Assurance Reulatory Affairs Engineering Research & Development Production Operations Consultants All personnel tasked with product, process, validations and cGMP responsibilities
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