Category: Webinar

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Risk Management of Biopharma Operations Over Lifecycle – An ICH Q12 Overview

Presented by: Dr. José C. Menezes, CSO, ValGenesis Join 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, […]

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Navigating the Path of Annex 1 Compliance: A Journey towards Regulatory Adherence and Batch Release

Presented by: Connie Leech, Global Director Quality, Compliance & Regulatory Affairs , CAI Top Reasons to watch Comprehensive 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 […]

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Digital Cleaning Validation Lifecycle

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 […]

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A Sustainable Model For Production System Excellence

Presented By: Woon Lit Ong, Senior Director, APAC & AfME Operational Excellence, Pfizer Global Supply and Rajnish Narula, Director, Business Excellence, Tuas, Pfizer Global Supply Learn 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 […]

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