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 […]