INTEGRATION OF ICH GUIDELINES IN EXISTING MANAGEMENT SYSTEMS FOR (BIO)PHARMACEUTICAL COMPANIES
Publikationen: Thesis / Studienabschlussarbeiten und Habilitationsschriften › Master Thesis (Universitätslehrgang)
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Publikationen: Thesis / Studienabschlussarbeiten und Habilitationsschriften › Master Thesis (Universitätslehrgang)
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TY - THES
T1 - INTEGRATION OF ICH GUIDELINES IN EXISTING MANAGEMENT SYSTEMS FOR (BIO)PHARMACEUTICAL COMPANIES
AU - Leitgeb, Stefan
N1 - embargoed until null
PY - 2011
Y1 - 2011
N2 - This work describes an approach for the implementation of ICH guidelines Q8 to Q11 in a generic management system for pharmaceutical companies. Special emphasis is given to emerging topics that are introduced in these guidelines like Quality by Design. It is described how the approaches can be employed and succesfully implemented in the organisation.
AB - This work describes an approach for the implementation of ICH guidelines Q8 to Q11 in a generic management system for pharmaceutical companies. Special emphasis is given to emerging topics that are introduced in these guidelines like Quality by Design. It is described how the approaches can be employed and succesfully implemented in the organisation.
M3 - Master's Thesis (University Course)
ER -
