The course is designed for people working in sterile manufacturing who have no or little knowledge of GMP.
You get to know the most important pharmaceutical regulations for sterile manufacturing and their importance,
You get a basic overview of general GMP requirements and specific requirements in sterile manufacturing and
You become familiar with the most important basic processes in sterile pharmaceutical production
Knowing and applying the GMP regulations is one of the key elements in the manufacture of medicinal products and medical devices. Particularly in the manufacture of sterile medicinal products, 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 the 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 answering this question and presenting the concrete transfer of regulatory requirements into practice. Where are the main difficulties and how can they be solved pragmatically? The course will present elements and situations which employees are regularly confronted with, like for example:
- Correct cleaning / disinfection
- Behaviour in clean rooms
- Correctly passing into the clean rooms
- Environmental Monitoring
- Performance of Media Fills