Quality management incl. GxP

Lecturer: Dr. Henning Voigt, Medical School Hannover (MHH) & Dr. Jens Gerdelmann, Fraunhofer Institute for Toxicology and Experimental Medicine (Fraunhofer ITEM) Description: Introduction to quality management, quality assurance and quality control. Topics include QM principles, organizational structures and processes, responsibilities, process orientation, continuous improvement, documentation, validation and qualification, risk analysis, audits and inspections, change and deviation management, CAPA, as well as GxP, accreditation and certification. Course duration: 4 hours and 20 minutes Language: German with English Translation

Lecturer: Dr. Henning Voigt, Medical School Hannover (MHH) Description: Role of Good Scientific Practice as part of GxP at the interface between basic research and clinical translation. Topics include GxP compatibility, risk-based project analysis, quality aspects related to personnel, facilities, equipment, methods, materials and documentation, and the question of when quality is “good enough” for the translational pipeline. Course duration: 1 hour and 30 minutes Language: German with English Translation

Lecturer: Dr. Jens Gerdelmann, Fraunhofer Institute for Toxicology and Experimental Medicine (Fraunhofer ITEM) Description: Introduction to Good Laboratory Practice: scope and regulatory background, GLP principles, organizational structure of a test facility, facilities and test systems, SOPs, conduct of GLP studies, QA inspections and regulatory oversight. Course duration: 1 hour and 30 minutes Language: English

Lecturer: N.N. Description: More information will be provided later Course duration: 2 hours Language: English

Lecturer: Dr. Carmen Puschmann, corlife oHG Description: This information will be provided later Course duration: 1 hour and 30 minutes Language: English