GMP for Beginners in Sterile Manufacturing
: 8 Oct 2019 - 9 Oct 2019
: Berlin, Germany
The course is designed for people working in sterile manufacturing who have no or little knowledge of GMP.
- Get to know the most important pharmaceutical regulations for sterile manufacturing and their importance,
- Get a basic overview of general GMP requirements and specific requirements in sterile manufacturing and
- Become familiar with the most important basic processes in sterile pharmaceutical production
- Introduction – What is specific for sterile manufacturing?
- Regulations for sterile manufacturing
- Microbiological basics
- Clean rooms and Barrier Systems
- Specific training requirements for sterile manufacturing
- Cleaning and disinfection
- Sterilisation processes
- Involvement of the microbiological lab
- Environmental monitoring
- Media Fill
- Handling failures in sterile manufacturing
- Inspections / Audits / Observations
- Workshop - Entering the clean area
This course is aimed at those who are new to sterile manufacturing.