Category: Webinar

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Cleaning Validation Demystified: A Comprehensive Guide and Case Studies

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 […]

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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 , 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 […]

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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 to […]

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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 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 […]

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CSV – Effective System Level Risk Assessment

Presented By: Rohit Tyagi, President, SAGAX TeamKey Highlights:Regulatory Compliance: How implementing robust CSV processes is essential for pharmaceutical companies to ensure product quality and patient safety, while remaining compliant with regulations. Risk Identification: Learn how to properly assess risk in using a computerized system focusing on patient safety. Data Integrity Assurance: Identifying potential DI impact […]

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  • Email: info@kenx.org
  • Phone: 858 649 3251
  • Email: info@kenx.org
  • Phone: 858 649 3251
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