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 […]
Presented By: Woon Lit Ong, Senior Director, APAC & AfME Operational Excellence, Pfizer Global Supply and Rajnish Narula, Director, Business Excellence, Tuas, Pfizer Global SupplyLearn about the design, deployment and sustainment of the Pfizer Production System called Integrated Manufacturing Excellence (IMEx, similar to the Toyota Production System TPS). IMEX helps to establish a standardized way […]
