Description
Target group
Employees from all good practice areas (GxP: GLP, GCP, GMP and others) in various functions are addressed. This includes technical personnel, test and project managers, quality management and quality assurance staff, archive managers, employees in management functions, but also people from other laboratories or institutions who want to learn about or deepen their knowledge of Good Practice and its current requirements when dealing with documentation and data (on paper but also electronically). Also addressed are interested parties who are active in ISO 9001 and related ISO-based QM systems.
Learning content
Diverse documentation on various aspects of 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, is to be conveyed to the participants in a holistic concept. 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.
