Presented by: Philip Jarvis, Director C&Q and Digital Validation Strategy, VEQTORHow digital validation tools are enabling validation 4.0Risk based data integrity processes (importance of data mapping and criticality of data) Building in Data integrity by design into digital validation systems Data integrity guidance watchouts – Bring paper into the digital world compliantly and defining “true […]
Presented by: Dr. José C. Menezes, CSO, ValGenesisJoin us for a webinar where we’ll delve into the practical application of ICH Q12 principles for biopharma operations. Biotech processes prior to QbD use control strategies that lack understanding of criticality and definition of CPPs or CQAs. Discover how to define these parameters from manufacturing history, and […]
Presented by: John Wrenn, Country Manager, Australia & New Zealand , CAICleaning validation can be a confusing topic for many people as there can seem to be conflicting information and guidance. This webinar will give you a broad overview of cleaning validation and describe the history and fundamentals of cleaning validation and how we arrived […]
Presented by: Connie Leech, Global Director Quality, Compliance & Regulatory Affairs , CAITop Reasons to watchComprehensive Overview: Get a comprehensive overview of Annex 1 and its role in ensuring the sterility and quality of medicinal products, empowering you with essential knowledge for your role in the industry. Expert Insights: Gain valuable insights from industry experts […]
Presented by: Rui Almeida, Director, Product Life Cycle Management Services, ValGenesis. Inc.Cleaning validation is a complex process. Over the years, the industry has moved on with a structured risk based lifecycle approach following FDA Process Validation Lifecycle principal guidance. Using old processes, it remains a challenge to eliminate human errors. This presentation shows how to […]
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