GMP Basics ATMP Edition

This training will give you an introduction to GMP requirements for both manufacturing of investigational ATMP and ATMP intended for the market. The training will give you a good overview of the EU requirements in EU GMP Part IV and with the emphasis of understanding the reason behind different requirements.

The training is divided into 10 parts. Each part is a short video that ends with some questions. You have to pass all questions before you can continue. After the successful completion of all parts and the tests, you will receive your Certificate of completion.

Content

• The background to GMP for ATMPs and how authorities perform oversight
• Important elements of GMP such as barriers used to minimise mix-ups, prevent contamination, prevent employee errors
• Understanding the importance of cleanroom controls and behaviour to achieve a relevant Sterility Assurance Level
• Systems to ensuring right quality, with high degree of assurance and to facilitate investigations
• Creating GMP records

Duration: 1 hour and 20 minutes

#8019