This Education Course is mainly concerned with the contents of international guidance documents and the draft of Annex 2 and special points which must be considered with regard to the development and production of bio-pharmaceuticals to assure the GMP compliance.
It covers the topics of routine and pre-approval inspection, registration in the field of biosimilars as well as in QC laboratory and production.
Furthermore the experience of biotech manufacturers as well as contract manufacturers will be highlighted by means of samples of clinical trial biologicals and fill and finish production.
The introduction to the new biotech facility and following site visit shows the practical implementation of GMP requirements.
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