Swiss Institute for Translational and Entrepreneurial Medicine (sitem-insel)

Translational Medicine and Biomedical Entrepreneurship

Module 2 - Good Manufacturing Practice and Quality Management

Content

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

Learning objectives

Participants gain an understanding of manufacturing processes and control strategies from labatories to commercial scale manufacture and become familiar with the concept of a Target Product.
At the end of this module, they have an understanding on the manufacturing process based on risk management, experimental studies and small scale industrial experience. Further, they are able to define a control strategy based on process and product unders-tanding and will have learned how the manufacturing process develops alongside within preclinical and clinical development.

Learning content

This module contains a virtual factory and general overview of the regulated industry, manufacturing and control development, manu-facturing and GMP and quality management.

Lecturers

Various experts from the industry, from UCB Farchim, Behring SA, meditec Consulting to Saq Qualicon to Cascination, as well as academia represented by the University of Mainz.

Start & Duration

January 2023

The completion of this module takes approximately 5 weeks.

Credits

5 ECTS

Fee

The cost of this standalone module is 5250.– SFr.

Reference

01.002

Module Leaders

Senior Director Global CMC Plasma Product Development, CSL Behring

Dr. Max Corbett

Max is the Senior Director, Head of Plasma Product Development CMC at CSL Behring. He manages a global team of CMC Leads responsible for new product development, which includes the definition and execution of (1) CMC packages to enable the phase specific process, analytical, formulation, and product development, (2) regulatory CMC strategy, documentation, & submissions, and (3) clinical manufacture & supply.

Markus Wipf

Markus Wipf has has been working in the medical device area since 1995, when he founded Axxos GmbH in 2007. Today, with Markus as CEO, Axxos GmbH provides quality management and conformity assessment services, has four certified auditors to perform both, internal and supplier audits according ISO or FDA requirements, compiles clinical evaluation reports and establishes technical files for the CE marking of medical devices.