EMEA-EFPIA 'Quality by Design' application workshop

• Date:
  Monday, 28 September 2009
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

Documents

EMEA-EFPIA 'Quality by Design' application workshop - Introduction

Regulators perspective on 'Quality by Design': QWP perspective - Jean-Louis Robert

Regulators perspective on 'Quality by Design': GMP/GDP Inspectors Working Group - David Cockburn

Regulators perspective on 'Quality by Design': BWP perspective - Kowid Ho

Integrated application of a QbD Development Approach across Chemical and Formulation Manufacturing Process

Continuous Quality Verification: an approach to process validation

Use of in-line near-infrared spectroscopy to monitor segregation of a pharmaceutical powder blend in a tablet press

The use of in vitro and in vivo data to define both design space and control strategy

QbD Development (derivation of CQAs, CPPs and design space using quality risk assessment and design of experiments on a scale-down model of the manufacturing process) of a novel therapeutic protein

Utilisation of QbD principles for the management of post approval changes for a novel recombinant monoclonal antibody

Next steps & closing remarks - Fergus Sweeney, Mike James