Date
- Monday, 28 September 2009, All day
Location
- European Medicines Agency, Amsterdam, the Netherlands
Documents
EMEA-EFPIA 'Quality by Design' application workshop - Introduction
English (EN) (191.88 KB - PDF)
Regulators perspective on 'Quality by Design': QWP perspective - Jean-Louis Robert
English (EN) (147.16 KB - PDF)
Regulators perspective on 'Quality by Design': GMP/GDP Inspectors Working Group - David Cockburn
English (EN) (214.19 KB - PDF)
Regulators perspective on 'Quality by Design': BWP perspective - Kowid Ho
English (EN) (1.07 MB - PDF)
Integrated application of a QbD Development Approach across Chemical and Formulation Manufacturing Process
English (EN) (215.61 KB - PDF)
Continuous Quality Verification: an approach to process validation
English (EN) (289.64 KB - PDF)
Use of in-line near-infrared spectroscopy to monitor segregation of a pharmaceutical powder blend in a tablet press
English (EN) (463.1 KB - PDF)
The use of in vitro and in vivo data to define both design space and control strategy
English (EN) (1.84 MB - PDF)
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
English (EN) (204.46 KB - PDF)
Utilisation of QbD principles for the management of post approval changes for a novel recombinant monoclonal antibody
English (EN) (267.86 KB - PDF)
Next steps & closing remarks - Fergus Sweeney, Mike James
English (EN) (227.83 KB - PDF)