Description
Target group
This course is aimed at employees from all areas of good practice (GxP: GLP, GCP, GMP and others) in various functions. This includes technical staff, test and project managers, quality management and quality assurance staff, archivists, management staff, but also people from other laboratories or institutions who want to get to know or deepen their knowledge of Good Practice and its current requirements in dealing with documentation and data (on paper but also electronically). Also addressed are interested persons who are active in ISO 9001 and related ISO-based QM systems.
Learning content
Diverse documentation on a wide range of aspects within quality (management) systems is a prerequisite and necessity for the preparation of dossiers that must be submitted to an assessment authority for approval. The importance of "data integrity" not only for data, but also for supporting documentation, will be conveyed to the participants in a holistic conception. Current expectations of authorities and viewpoints from professional societies will be conveyed and presented in a plausible and comprehensible manner with practical examples. In addition, implementation options for achieving an appropriate level of data integrity will be discussed with the participants.
Speaker
Dr. Karl Kleine (graduate chemist)
You can find a full overview of the event here.