GMP for Vaccine Manufacturers

The development and production of vaccines makes high demands on the manufacturing pharmaceutical industry. The special requirements on handling and safety with live organisms necessitate measures which exceed the requirements of classic pharmaceutical manufacturing.

Topics like, the enhanced risk of cross-contaminations, questions about individual safety of staff and the issues of cleaning and disinfection of rooms and equipment concern a vaccine manufacturer in a considerable scale.

Specifically the demands of the necessary bio safety classes with negative pressure of rooms versus that of aseptic processing with positive pressure requires a well thought out design of vaccine facilities.

Also the safety of the environment and the waste disposal should be receiving proper attention already in the design phase. But the dedicated requirements on staff safety are although a challenge in vaccine manufacturing.

This Course should give you the possibility to see the theoretical background as well as the practical implementation of GMP requirements in the vaccine production. A combination of theoretical requirements and practical case studies is the best way to learn this.

Speakers from regulatory bodies, consulting and practising experts will give you the chance to get to know the different views and participants will have ample opportunity to discuss with speakers and other participants about specific issues.