Description
Target Audience
This course is intended for employees from all Good Practice areas (GxP: GLP, GCP, GMP, and others) in various roles. This includes technical staff, test and project managers, quality management and quality assurance personnel, archive managers, and employees in management roles, as well as individuals from other laboratories or institutions who wish to learn about or deepen their understanding of Good Practice and its current requirements when handling documentation and data (both on paper and electronically). The course is also aimed at those interested in ISO 9001 and related ISO-based QM systems.
Course Content
Comprehensive documentation covering a wide range of aspects within the framework of quality (management) systems is a prerequisite and necessity for the preparation of dossiers that must be submitted to a regulatory authority for approval. The importance of “data integrity”—not only for data but also for supporting documentation—will be conveyed to participants within a holistic framework. Current expectations of regulatory authorities and perspectives from professional societies will be presented, supported by practical examples that are clear and easy to understand. Additionally, implementation strategies for achieving an appropriate level of data integrity will be discussed with the participants.
Speaker
Dr. Karl Kleine (B.S. in Chemistry)
You can find a complete overview of the event here.
