English abstract
This two-day course is the perfect introduction to the principles of GMP for employees that work with production of sterile medicinal products. During the course you will be introduced to the current GMP regulations, and you will understand better why compliance with GMP is important in everyday routines when focus is on the best quality of the medicinal product.
The theory behind the GMP requirements is presented in different ways to accommodate all learning styles so you will play games, work your way through quizzes and various tests. The instructors will share relevant examples from their experience from Life Science and ensure that you will be equipped theoretically and practically to ensure GMP compliance.
To make sure that you have the right understanding of what is needed when working with sterile medicinal products, you will be introduced to the requirements to the personnel, to the design of premises and equipment, microbiology, aseptic techniques, environmental monitoring, smoke studies and Aseptic process Simulation.
After the course you will have the right understanding if the correct GMP mindset and will be aware of what behaviour is needed to comply with instructions in your work environment, and you will be ready to be trained in daily work functions. A prerequisite for this course is prior participation in a GMP course. This could be Basic GMP for new operators or GMP 1.
The target group is new operators in production.
The course language is Danish.
You will meet: Helge Rolighed Christensen
Download the English abstract below, including a full course description in Danish
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