GMP Archives - Kenx Members

Category: GMP

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Driving Organization Change in the Era of AI

Presented by: Diego Amesquita, Director, Business Transformation, Main & Mission The rapid adoption of Artificial Intelligence (AI) in the Life Sciences industry is transforming how organizations operate, think, and govern. As AI reshapes the landscape, it is imperative to implement robust Organizational Change Management (OCM) strategies to ensure a smooth and successful transition. In this […]

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Role-based Talent Planning for Operational Readiness

Created by: Harry Benson, Director, Human Performance, CAI This paper intends to provide guidance on talent planning, with specific emphasis on role clarity. Given the flurry of activity being conducted during capital projects and transitions to operations, developing a talent plan may appear to be somewhat administrative or insufficiently urgent. This often leads site leaders […]

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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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Establishing CAPA to Support Your Investigation And Promote Continuous Improvement

Presented By: LeAnna Pearson, Associate Director Quality Compliance & Regulatory, CAI Part 1 – CAPA 101 back to basics• Understand the purpose and history behind the CAPA• Understand what the FDA is expecting from your CAPA• Understand when to use a CAPA• Review the typical CAPA processPart 2 – Building blocks of an effective CAPA […]

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Category: GMP

Driving Organization Change in the Era of AI

Role-based Talent Planning for Operational Readiness

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

Establishing CAPA to Support Your Investigation And Promote Continuous Improvement

Data Integrity Program Management and Process Mapping

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