Get a solid introduction to GMP and the EU’s regulations for pharmaceutical manufacturing, and build a fundamental understanding of the requirements, responsibilities, and mindset needed to produce safe, high-quality medicines.
In this course, you will gain a basic knowledge of the rules and standards that form the foundation of Good Manufacturing Practice (GMP).
You will be introduced to the life sciences industry and the journey of a medicine to the market, so you understand the connection between legal requirements, quality, and patient safety. We will explore the requirements of the EU GMP guidelines (EudraLex Volume 4) in depth. You will work with key topics such as the pharmaceutical quality system, risk management, requirements for production, personnel, facilities and equipment, as well as documentation.
The training alternates between presentations, discussions, exercises, and GMP simulations. This approach provides both theoretical knowledge and practical understanding, as well as opportunities to network and exchange experiences with other participants. You will gain a broad understanding of why compliance with GMP is essential to ensure patients have access to safe, high-quality medicines.
This course can also be conducted on-site at the company - see here
You can find the course in Danish here.
At the course you will meet:
Tine Gjerding Dahlberg, Educational Consultant, Pharmakon
Julie Dersch, Educational Consultant, Pharmakon
The course is aimed at academics and technicians who are inexperienced with GMP, as well as new employees in the life sciences industry who need a basic understanding of GMP.
It is also suitable for those already working with GMP who want a deeper understanding of the rationale behind their work and the GMP regulations.
The course is a two-day course. Accommodation is included.
Day 1: 09.00 – 21.00
Day 2: 09.00 – 16.00
The course consists of presentations, discussions and exercises.