The Affiliate D/A/CH is working in regional Workgroups in the global Communities of Practice / CoP
organization. These "Communities of Practice" enable the international communication on a technical basis
including documents as White Papers, etc. This global Network enables the direct and personalized
communication between all ISPE members dedicated to the CoP.
With the new "risk-based approach" and the PAT Guidance published to outline it, the FDA has started a paradigm change in pharmaceutical manufacturing and control. This entails new challenges for the pharmaceutical industry.
The objective of PAT CoP is to master these challenges with a comprehensive exchange of experience and information among industry, suppliers and regulatory authorities.
The group is internationally represented in ISPE through the ISPE PAT CoP (Community of Practice) Steering Committee which has tight direct contact with the FDA.
Contact: Christian Wölbeling (Contact refer to Member Directory)
The goals of the CoP "Water and Steam" are to provide to industry experts of this area a platform for the discussion of subject matter topics and the exchange of experiences. Furthermore this group will be actively involved in future revisions of the Baseline-Guide Vol. 4 "Water & Steam." In order to achieve these goals roundtable discussions and workshops on topics related to pharmaceutical water and steam are conducted annually. The topics are selected by the participants.
Networking with the respective CoP's in other affiliates will enable an international exchange of ideas and experiences.
Contact: Bruno Walcher (Contact refer to Member Directory)