ICH Q9 (R1): Guidance on implementation | Peer Schmidt & Michael Schousboe

Course Program

The course is structured into two 2-hour modules. During the course the following topics will be explored in depth:

Session 1:

• Changes in Revision 1 of the ICH Q9 Guideline
• Hazard identification vs. risk identification
• Subjectivity in Quality Risk Management
• Formality

Session 2:

• Risk-based Decision-Making
• Product Availability
• Risk review

Why choose our course?

With the contribution of two highly qualified members of the ICH Q9 (R1) Expert Working Group, this training course will offer the opportunity for a deep understanding of the requirements of this crucial guideline and their implementation in various areas of pharmaceutical operations.

This training course will allow easy interaction with the two Subject Matter Experts who will be happy to take any questions from participants.

Teachers

Peer Schmidt

Director Global Quality Systems, brings more than 20 years of experience in the development, manufacturing, registration and supervision of Medicinal Products, Medical Devices and Combination Products. Peer studied Biology in Bonn, Munich and Edinburgh, and holds a Ph.D. in Molecular Biology from the University of Munich. Peer oversees Quality Risk Management at AbbVie and is a member of the ICH Q9 Revision 1 Expert Working Group.

Michael Schousboe

Michael Schousboe, Senior QMS Specialist, Quality Risk Management, has more than 25 years of experience from different pharmaceutical companies, and has worked with both drug substance, drug product, medical devices and combination products.
Michael holds a Master’s degree in pharmaceutical science (M.Sc. Pharm.) from the Royal Danish School of Pharmacy, and a design for six sigma black belt. Michael is managing the Quality Risk Management Process at Novo Nordisk A/S, and is a member of the ICH Q9R1 Expert Working Group

Who's It for?

Technicians and managers of the GMP Company Functions of Quality Assurance, Quality Control, Technical Service and Production.

EIPG member

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