Risk management (QRM)

Get methods and concrete tools to reduce risks in your own systems and ensure patient health in the health in the pharmaceutical industry. Quality Risk Management (QRM) is a central part of a GxP company's Quality Management system and includes a systematic process for identifying, assessing and managing risks in the product product lifecycle.

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Who can participate?

This course is aimed at those involved in GxP activities in management, QA, development, operations or another technical area who want more knowledge and tools in risk assessments.

Course overview

Confirm Knowledge Center
Havnevej 1, 1 tv, 4000 Roskilde
Danish / English

Prerequisites to participate

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Risk management (QRM)

Risk management is fundamentally about protecting patients from the risk of harming their health by consuming products manufactured by the pharmaceutical industry.

Quality Risk Management (QRM) is an essential part of a GxP company's overall Quality Management System and includes a systematic process used to identify, assess and take control of the risk that exists during the entire lifecycle of a product.

Both the US and European GxP guidelines (FDA's Guidance to Industry Q9 Quality Risk Management and the European ICH-Q9, respectively) include risk management and both are included in the course.

Course information

Teaching method

The course is offered in Danish and English, the course material will be in English.

The teaching is a mix of theory, practical exercises and examples from the industry and is based on ISPE guidelines and Q9.
This teaching method supports our desire for the introduction to principles and methods to be practically oriented and based on the problems that you and the other course participants work with in everyday life.

It is possible to ask questions and provide input on an ongoing basis, and we value the dialog with the participants. Discussions of your own experiences during the course are encouraged, as these can help increase the knowledge and understanding of everyone present.

To make our courses even better, we always ask our students to evaluate the course at the end.

Course highlights

On the course you will achieve:

In-depth knowledge of the principles behind risk management according to ICH-Q9 and the 3 risk categories that need to be addressed when working with pharmaceutical production.
Competencies to assess, analyze and evaluate risks within your own work area.
Insight into the methods and tools you need to effectively design and maintain regulatory documentation.

Course program

After the course

Instructors on the course

Jeppe Lund Schmidt

Jeppe works in our validation team on a daily basis. He has GMP experience from several large remodeling projects in pharmaceutical packaging plants and countless validations of everything from simple transmitters to large complex IT systems. He has produced and read a wide variety of documentation and has visited companies and sites across the country. He has worked with manufacturers of both pharmaceuticals and medical devices and incorporates his experience in the industry into his teaching. Jeppe has several years of teaching experience and teaches several of our other courses, including GAMP5 and Data Integrity.

Testimonials from learners

Learner on Introduction to GAMP 5
Really good and professionally strong presentation. The trainer found the right professional level for the group and initiated good tasks and resulting discussions. And super with small breaks every hour.
Learner on Introduction to GAMP 5
Many thanks and much praise to Katrine! As a teacher, you are present, relevant, a skilled communicator and very pleasant. You manage to bring your experience from both teaching and practice into play in the context in which we ask the questions.
Learner on Introduction to GAMP 5
I think it was good to mix the theory and the practical part. The teacher was super good at explaining and super good at pulling out examples that supported the theory.
Trainee at Data Integrity
The benefit of the course is a quick and processed approach to the ISPE guide.
Trainee at Data Integrity
It was a great course that lived up to all expectations. Super good teacher 🙂
Trainee at Data Integrity
Really good course... even after many hours you are still in it... course leader can maintain focus and interest
Course participant on SattLine programming
A good structure of course material and balance between theoretical material and exercises. The theoretical parts gives food room for more in depth questions of interested.
Course participant on SattLine programming
Very motivated course-responsible, very pationate and patient.
Trainee at Data Integrity
Good with exercises and quizzes. Good location and delicious food/catering.
Course participant on SattLine programming
Super teacher 👍😁

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