The course focuses from the basics and fundamentals of Good Manufacturing Practice (GMP) through User Requirement Specification (URS), Validation, Deviations and Facility Planning. Moreover Radiation Safety, the question how to build up and manage a quality risk management system will be covered in the course. Additionally it explains the increasing regulatory demands from laboratory work to clinical trials, going from laboratory notes to an Investigational Medicines Product Dossier (IMPD).
This event will be accredited with CME credits (to be converted into AMA credits).
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