740924 Pharmaceutical core subjects I

winter semester 2012/2013 | Last update: 06.02.2013 Place course on memo list
740924
Pharmaceutical core subjects I
UE 1
1
Block
not applicable
English
According to regulatory organizations any assay procedure that is used for pharmaceutical purposes (e.g. during manufacturing of drugs or confirming the quality of finished products) needs to be validated. This comprises the determination of parameters that indicate / confirm that the selected procedure (analytical method) is suitable for its intended use. This course will introduce PhD students to the principles, requirements, and practical realization of method validation, emphasizing on chemical (chromatographic) methods, but briefly also addressing bioanalytical assays.
At first, validation theory and design, as well as standards of regulatory institutions like ICH or FDA will be outlined and discussed (half day). This is followed by one day conducting the practical validation of an analytical method under guidance. In order to provide the participants with the highest possible benefit, group projects will then be handed out, so that the students can apply and recapitulate the previously mediated facts in their own scientific environment. The seminar will be concluded by the presentation and discussion of the obtained results (half day). The seminar is specially recommended for those attempting careers in industry or academia.
Group 0
Date Time Location
Wed 2013-01-23
10.00 - 12.00 L.03.121 L.03.121