The ISPE – DACH Working Groups

The ISPE affiliate DACH gets involved through regional working groups with the international ISPE organization of CoP’s. Those “Communities of Practice” allow international, subject matter oriented communication, as well as preparation and exchange of working papers. The global network supports exchange of experience by direct and personal interaction of regionally and internationally organized members of ISPE.
Join us and send an e-mail to the respective contact person.

Six regional work groups exist currently in the ISPE-DACH:

ispe_pat_Group 1: Regional CoP Process Analytical Technologies (PAT)
The FDA initiated a paradigm change in pharmaceutical manufacturing and quality control introducing the new risk based approach and the related published PAT guidance. This results in new challenges for the pharmaceutical industry. The PAT CoP aims to cope with this challenge by thorough exchange of experience and information between industry, suppliers and authorities. The group is represented in ISPE International in the ISPE PAT CoP Steering Committee, which works in close collaboration with the FDA.

Contact: Michael Voss (michael.voss(at)mc-mvoss.org)
Link to the CoP-site: click here.

ispe_wasserdampf_Group 2: Regional CoP Pharma-Wasser und Dampf (water and steam)
Main purpose of the CoP „water & steam“ is to offer a platform for experts in the pharmaceutical industry to discuss specific subject topics and exchange experience. Beyond that, this group will continue to actively engage in future updates of the Baseline® guide Vol.4 “water & steam”.
Those objectives shall be pursued in annual expert talks on topics, co-determined by the members, around “water & steam”. Through communication with the CoP’s of other affiliates, experiences can be shared continuously.

Contact: Bruno Walcher (bruno.walcher(at)ispe-dach.org)
Link to the CoP-site: click here.

ispe_containment_Group 3: Regional CoP Containment
Main purpose of the CoP „Containment“ is to offer a platform for operating companies, production engineers, manufacturers and interested people, who are concerned with containment systems in their occupational routine, to discuss specific subject topics and exchange experience. Those objectives shall be pursued in annual expert talks on topics around “Containment”. Through communication with the CoP’s of other affiliates, experiences can be shared continuously. The emphasis of the team is currently the compilation of a “Containment manual”.

Contact: Richard Denk (r.denk(at)hecht.eu)
Link to the CoP-site: click here.

ispe_gamp_Group 4: Regional CoP Good Automation Manufacturing Practice (GAMP)
The regional CoP GAMP D-A-CH has the goal and purpose to increase acceptance, awareness level and application of the actual GAMP-guideline in the life science industry, their suppliers and the authorities of the German-speaking countries Germany (D), Austria (A) and Switzerland (CH). In addition, this CoP offers a neutral platform for knowledge exchange and contributes to further development and continued success of the GAMP-guideline.

Contact: Prof. Hartmut Hensel (hartmut.hensel(at)ispe-dach.org)
Link to the CoP-site: click here.

ispe_projektmanagement_Group 5: Regional project management
Engineers work with, in and on projects. Project management of such typically highly complex venture is of utmost importance: The project team is accountable for due dates, cost control and final outcome. In conjunction with external suppliers and service providers, this means a complex entity. In our work shops, we learn through exchange of experience. The group meets with interested people at least once a year, typically in first quarter, and deals with one major topic. We also look at the wider picture and discuss with experts of other industries, such as automotive, aviation or food. Come join us!

Contact: Dr. Werner Seiferlein (werner.seiferlein(at)ispe-dach.org)
Link to the CoP-site: click here.

ispe_energieeffizienz_Group 6: Regional energy efficiency
Energy consumption in the pharmaceutical industry (laboratory and production) is one of the major and continuously increasing cost factors. To discuss and to point out the main drivers we will meet. In our work shops, we learn through exchange of experience. The group meets with interested people at least once a year, typically in last quarter, and deals with one major topic. We also look at the wider picture and discuss with experts of other industries. Come join us!

Contact: Dr. Werner Seiferlein (werner.seiferlein(at)ispe-dach.org)
Link to the CoP-site: click here.