EMEA-EFPIA 'Quality by Design' application workshop
Date:
28/09/2009 to 29/09/2009
Location:
London
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EMEA-EFPIA 'Quality by Design' application workshop - Introduction (PDF/191.88 KB)
First published: 28/09/2009
Last updated: 28/09/2009 -
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Regulators perspective on 'Quality by Design': QWP perspective - Jean-Louis Robert (PDF/147.16 KB)
First published: 28/09/2009
Last updated: 28/09/2009 -
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Regulators perspective on 'Quality by Design': GMP/GDP Inspectors Working Group - David Cockburn (PDF/214.19 KB)
First published: 28/09/2009
Last updated: 28/09/2009 -
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Regulators perspective on 'Quality by Design': BWP perspective - Kowid Ho (PDF/1.07 MB)
First published: 28/09/2009
Last updated: 28/09/2009 -
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Integrated application of a QbD Development Approach across Chemical and Formulation Manufacturing Process (PDF/215.61 KB)
First published: 28/09/2009
Last updated: 28/09/2009 -
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Continuous Quality Verification: an approach to process validation (PDF/289.64 KB)
First published: 28/09/2009
Last updated: 28/09/2009 -
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Use of in-line near-infrared spectroscopy to monitor segregation of a pharmaceutical powder blend in a tablet press (PDF/463.1 KB)
First published: 28/09/2009
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The use of in vitro and in vivo data to define both design space and control strategy (PDF/1.84 MB)
First published: 28/09/2009
Last updated: 28/09/2009 -
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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 (PDF/204.46 KB)
First published: 28/09/2009
Last updated: 28/09/2009 -
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Utilisation of QbD principles for the management of post approval changes for a novel recombinant monoclonal antibody (PDF/267.86 KB)
First published: 28/09/2009
Last updated: 28/09/2009 -
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Next steps & closing remarks - Fergus Sweeney, Mike James (PDF/227.83 KB)
First published: 28/09/2009
Last updated: 28/09/2009