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Drug manufacturing represents cost-intensive proceeding which has to follow accurately to international guidelines and directives. International authorities such as Food and Drug Admistration (FDA) and European Medicines Agency (EMA) are responsible for approval of therapeutic agents. Good Manufacturing Practice (GMP) compliance of manufacturers is obligatory for successfull approval.
Prospective project managers dealing with GMP compliance have to face enormous documentation requirements in different areas of drug manufacturing. Their responsibilty is focussed on setup of documentation structures for maintenance of quality and safety.
This seminar deals with current regulatory affairs in Good Manufacturing Practice directed by US agency FDA. Relevant guidelines for compliance and documentation requirements for development and production are illustrated.