GMP basics

Good Manufacturing Practice (GMP) provides the structure for documentation in Life Science, making it one of the most important tools in the industry to ensure patient safety.

Who can participate?

Anyone interested in gaining basic knowledge in GMP.
Quality, production, development, QC (quality control) personnel.
People with positions in the Life Science industry such as:
Engineers.
QC employees.
Technicians.
Operators.
Suppliers to GMP regulated companies.

Course overview

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

Prerequisites to participate

There are no prerequisites to participate in the course. The course is aimed at both those new to the industry and those with some experience.

Read more about the course

GMP basics

Get a comprehensive introduction to Good Manufacturing Practice (GMP), essential in the Life Science industry to ensure patient safety and product quality. The course covers current European GMP regulations and key concepts, providing you with both theoretical knowledge and practical skills that you can implement in your daily work.

Course information

Teaching method

You will learn how to identify important functions for patient safety, product quality and data integrity, facilitate risk assessments and apply appropriate methods to evaluate risks. The course combines theory, practical exercises and industry examples and is based on ISPE guidelines and GMP.

We encourage ongoing dialog and sharing of experiences to promote learning. At the end of the course, we ask for learner evaluation to improve our teaching.

Course highlights

On the course you will achieve:

In-depth knowledge of risk management principles according to ICH-Q9 and the three risk categories in pharmaceutical manufacturing.
Competencies to assess, analyze and evaluate risks in your work area.
Methods and tools for efficient design and maintenance of regulatory documentation.

Course program

After the course

Catering

Morning coffee and bread.
Breakfast and lunch
Afternoon coffee and cake.

Instructor on the course

Jeppe Lunde 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 both pharmaceutical and medical device manufacturers and brings his industry experience to his teaching. Jeppe has several years of teaching experience and teaches several of our other courses, including GAMP5 and Data Integrity.

Testimonials from learners


Do you have any questions?

Contact us

If you have any questions regarding our courses, we are ready to help you. Write to us