Knowing and applying the GMP regulations is one of the key elements in the manufacture of medicinal products and medical devices.
In the manufacture of sterile medicinal products, in particular, employees have to comply with extensive requirements.
Against this background, employees have to know the GMP requirements and must know how to use them in practice.
The question is: how can employees implement, in their daily work, regulations which are usually formulated in a very general manner?
The aim of the course is to help answer this question and enable the concrete transfer of regulatory requirements into practice.
Where are the main difficulties and how can they be solved pragmatically?
The course will examine challenges which employees are regularly confronted with, such as:
- Correct cleaning / disinfection
- Behaviour in clean rooms
- Correctly passing into the clean rooms
- Environmental Monitoring
- Performance of Media Fills