Lecturers: Dr. Heinrich Prinz (PDM-Consulting), Dr. Christoph Prinz (Head of Quality Assurance GMP & Qualified Person of the company "BioNTech SE")
Topics of the workshop
In this workshop, you will learn the basic requirements for a quality management system and gain insight into concrete activities, such as risk analysis for a manufacturing process and conducting audits in the quality assurance environment of a pharmaceutical product. You will also learn about the requirements of clinical trials, which are a basic prerequisite for the marketability of pharmaceuticals. You will learn in detail, which activities and tasks quality control must fulfill and cover in a pharmaceutical company. The distinction between quality assurance, manufacturing and the tasks of the legally responsible persons, in particular the Qualified Person, is important here.
- Regulatory requirements for the manufacturing of drugs (Content and structure of the regulations for the manufacturing of drugs in respect to development, production, registration and distribution)
- What does GMP mean – „What do I need to know about GMP in the pharmaceutical environment? What are the differences between GMP – GLP – GCP
- Legal Responsibilities
- GMP and Quality Management
- GMP and the Production of a Medicinal Product
- GMP and the Quality Control of Medicinal Product
- Performance of clinical trials
- ATMP’s, Protein Engineering, Tissue Engineering
- Medical devices, Combination products
Lecturer
Dr. Heinrich Prinz studied chemistry and genetics and worked for many years in the pharmaceutical industry, where he was responsible for quality management in the pharmaceutical, medical devices and diagnostics sectors. His main focus is on the development and implementation of quality management systems according to GMP Part I and II and integrated management systems as well as the execution of audits and trainings. With PDM-Consulting he advises companies in the production of pharmaceuticals, medical devices and in-vitro diagnostics regarding quality management and trains employees as well as PhD students.
Location: Presence (presence is planned otherwise online, no hybrid course)
ECTS: 1
Participants: max. 20
Registration for the workshop via Stud.IP (winter term 2022/2032)
Organized by OLTECH
contact: oltech@uol.de