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 […]
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 […]
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 […]
Presented By:Kim Huynh-Ba, MS, PMP, FAAPS, Managing Director; Adjunct Faculty, Pharmalytik Consulting; RAQA, Temple University
Presented By:Pedro Ferreira, Quality Risk Management Tech Lead, ValGenesis Margarida Ventura, Quality Risk Management Consulting Lead, ValGenesis Dr. Iris Ziegler, Director Pharmaceutical Sciences and QbD, Corden Pharma International Part 1 – Commercial and Lifecycle Implementations of Quality Risk Management• Draw a baseline on what QRM is in terms of goals and context• Understand the QRM […]
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