sitem-insel AG

M2 - Good Manufacturing Practice and Quality Management

Module leaders: Dr. Max Corbett, CSL Behring
Markus Wipf, AXXOS GmbH

Date and Credits

Start: 18.01.2021

Duration: 5 Weeks


This module focuses on the understanding of the needs to establish and maintain the level of excellence required by regulatory agencies.

Learning objectives

  • Understanding of manufacturing process & control strategy from lab to commercial scale manufacture
  • Being familiar with the concept of a Target Product


  • Understanding of the manufacturing process based on risk management, experimental studies and small scale industrial experience
  • Definition of a control strategy based on process and product understanding
  • Understanding how the manufacturing process develops alongside within preclinical and clinical development

Learning content

  • Virtual factory and general overview of regulated industry
  • Manufacturing and control development
  • Manufacturing and GMP
  • Quality management

Module leader

Dr. Max Corbett, Behring SA


Various experts from industry (UCB Farchim, Behring SA, meditec Consulting, Saq Qualicon, Cascination) and academia (University of Mainz)