sitem-insel AG

Quality management and GMP

Module leader: Dr. Max Corbett, CSL Behring



Date and Credits

5 ECTS

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

Profile

  • 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

Lecturers

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