740924 Pharmaceutical core subjects I
winter semester 2018/2019 | Last update: 08.10.2018 | Place course on memo listAccording 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, this will be done in smaller groups, so that the students can apply and recapitulate the previously mediated facts individually. The seminar will be concluded by the presentation and discussion of the obtained results. The seminar is specially recommended for those attempting careers in industry or academia.
Laboratory course
Confirmation of participation
Will be discussed in the first lesson.
Subject to alteration.