Quality Risk Management for ATMP and Pharmaceutical Industry 03. AprilApr. 2025 08:00 - 17:00

Flemingsberg Business Community

Are you working in ATMP or the pharmaceutical industry and looking to strengthen your expertise in risk-based quality management? Sign up for the GBA Key2Compliance Quality Risk Management course and gain the knowledge and tools to ensure compliance and drive efficiency in your organization. As a ATMP community member, you get a 15% discount on the course, email Josefine.bresmar@flemingsbergscience.se to know more.

Quality Risk Management (QRM) is an area that has become increasingly important in the pharmaceutical industry and where expectations regarding a risk-based approach have increased increasingly from the authorities.

What to expect?

In this basic quality risk management course, you will be introduced to important basic concepts and also introduced to some of the tools that are commonly used.  However, the focus is on understanding why it is important and value-creating to work in a risk-based way and to highlight how this is used in the pharmaceutical industry and what is important to do this successfully.

The course is largely based on the risk management flow described in ICH Q9 where each part of it is reviewed to identify and discuss difficulties you may encounter in the different steps, and how to best work to overcome them.

Is This Course Right for You?

The course is aimed at those who work in or close to pharmaceutical manufacturing and need an introduction to a risk-based approach. Perhaps you often participate in such work and need a greater understanding of what factors are important for success. Or you work overall within the organization, perhaps as a manager, and need to understand the concepts, what requirements exist and what is important for you as an organization to succeed with your quality risk work in an efficient and value-creating way.

When? April 3rd
Where? Innovation Station Flemingsberg.

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