Science Slam 2024

The Science Slam will take place again on May 29, 2024. We are still looking for slammers. More information here.

The third German Postdoc Appreciation Week will take place from September 16-20, 2024. Stay informed here: https://paw-germany.de/.

Contact

Dr. Susanne Elpers
Officer for Early Career Researchers with a focus on Postdocs and Equal Opportunities

+49 (0)441-798 2939

Dr. Julia Anna Matz
Officer for Early Career Researchers  with a focus on Doctoral Candidates and International Issues

+49 (0)441-798 4286

Dr. Sandra Wienand
Officer for Early Career Researchers  with a focus on Doctoral Candidates and International Issues

+49 (0)441-798 2914

Office

Sabine Osterkamp

+49 (0)441-7984628

Event

Events

Good Manufacturing Practice (GMP, GLP und GCP) basics and extended requirements in the pharmaceutical environment

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

13.02.2023 09:00 – 14.02.2023 17:00

(Changed: 05 Mar 2024)  | 
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