Created by: Valerie Mulholland, Senior Director / Principle Consultant, GMP Services Ltd & Anne Greene, Director PRST, Technological University, DublinThe Pharmaceutical Regulatory Science Team (PRST) founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing Science and Risk based decision making and manufacturing approaches. Since its inception, the PRST […]
Created by: Jennifer Spiegler, Staff Validation Engineer at Janssen Biologics Leiden, the NetherlandsIn traditional monoclonal antibody (mAb) manufacturing, the first purification process step of crude harvest (obtained from cell culture) is Protein-A Chromatography. This expensive column resin is often under-utilized for clinical or orphan drug products since the chromatography columns are dedicated per product. In […]
Presented By: LeAnna Pearson, Associate Director Quality Compliance & Regulatory, CAIPart 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 Strategy• […]
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 InternationalPart 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 lifecycle […]
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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