About the Webinar
The pharmaceutical gases utilized have to fulfil a number of high requirements because it often comes into direct contact with the product or product intermediates. There are various regulations, such as EU GMP, FDA and the European Pharmacopoeia, but these do not define pharmaceutical gas quality for individual applications. There is more guidance available on sterile application. In order to specify all relevant parameters a number of associated norms and guidelines are referenced. Additional confusion exists also around the differentiation between medicinal and pharmaceutical gases. There will be an overview on the applicable regulations, norms and guidelines and also some common practices.
About Stephan Neumann
Stephan has a M.Sc. In Utility Engineering and is pursuing a M.Sc. in Pharmaceutical Microbiology. He works for Boehringer Ingelheim since 2002 and his role is " Global Governance Critical Utilities". He is providing support to all production sites in the network. This encompasses hands-on site support, audit (response) support, trouble shooting, training, site improvements and much more . He is also a member of the Global ISPE Critical Utilities group where he did contribute to a number of ISPE Good Practice Guides.
Stephan is also a member of the Medicinal Gases Working group of the German Pharmacopeial Commission.
11 май 2022
