EMEA-EFPIA 'Quality by Design' application workshop

Event

Irish is available via eTranslation, the European Commission's machine translation service.

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Date

Dé Luain, 28 Meán Fómhair 2009, All day

Áit

European Medicines Agency, Amsterdam, the Netherlands

Documents

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

English (EN) (191.88 KB - PDF)

Foilsíodh den chéad uair é: An nuashonrú is déanaí:
Amharc

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

English (EN) (147.16 KB - PDF)

Foilsíodh den chéad uair é: An nuashonrú is déanaí:
Amharc

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

English (EN) (214.19 KB - PDF)

Foilsíodh den chéad uair é: An nuashonrú is déanaí:
Amharc

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

English (EN) (1.07 MB - PDF)

Foilsíodh den chéad uair é: An nuashonrú is déanaí:
Amharc

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

English (EN) (215.61 KB - PDF)

Foilsíodh den chéad uair é: An nuashonrú is déanaí:
Amharc

Continuous Quality Verification: an approach to process validation

English (EN) (289.64 KB - PDF)

Foilsíodh den chéad uair é: An nuashonrú is déanaí:
Amharc

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)

Foilsíodh den chéad uair é: An nuashonrú is déanaí:
Amharc

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

English (EN) (1.84 MB - PDF)

Foilsíodh den chéad uair é: An nuashonrú is déanaí:
Amharc

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)

Foilsíodh den chéad uair é: An nuashonrú is déanaí:
Amharc

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

English (EN) (267.86 KB - PDF)

Foilsíodh den chéad uair é: An nuashonrú is déanaí:
Amharc

Next steps & closing remarks - Fergus Sweeney, Mike James

English (EN) (227.83 KB - PDF)

Foilsíodh den chéad uair é: An nuashonrú is déanaí:
Amharc

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