In the course "GMP und Qualitätssicherung" the basics of Good Manufacturing Practice are presented. This mainly concerns pharmaceutical and biotechnological production, which is strongly subject to regulatory requirements and has to comply with high-quality standards. Following the GMP basics, validation fundamentals and examples of validation "how-to-do" are given. The description of plant qualification, change control, and change management round off the event. Occupational health and safety, pharmaceutical production processes, and environmental risk assessment safety are also covered. Examples are used to reinforce the knowledge imparted.
Daily updated information and lecture-related materials are available in the Moodle course.