GAMP D-A-CH

• Forum member pages
• SIG Small Devices
• SIG "Collaboration models between users and suppliers"
• SIG "Open Source Software"
• SC member pages

Mission  
The mission of GAMP D-A-CH is to broaden the acceptance, knowledge, and usage of the current GAMP Guide within the life-sciences industries, suppliers, and regulatory bodies in the German speaking countries Austria, Germany and Switzerland, to establish a neutral platform for information exchange and to contribute to the further development and success of GAMP. 
 
Organization 
The GAMP D-A-CH Forum is a sub-organization of ISPE D/A/CH and the VDI/VDE Society Measurement and Automatic Control (GMA). It is managed by a Steering Committee consisting of seven members of which at least three should be representatives of the life-sciences industries, one from the regulatory body and the remaining from suppliers, consultants or academia. The Steering Committee is lead by a chairperson and a vice-chairperson serving for:

• Chairperson: referring to ISPE D/A/CH Chairman and to the Chairman of the GMA specialist area and represents GAMP D-A-CH Forum in the GAMP Europe Steering Committee and in the GAMP Council
• Vice-Chairperson: referring to the Chairman and is responsible for the synergies with the Secretary of ISPE D/A/CH as well as VDI/VDE-GMA

The GMA headquarters provide for secretarial services. 

GAMP D-A-CH-Steering Committee

Joining GAMP D-A-CH
There is no pre-requisite to become a member of the GAMP D-A-CH Forum. To obtain membership please follow the link www.vdi.de/gma/gamp-dach/neu. Please state your complete name, name and postal address of the company and include telephone number and e-mail address in request for membership. Please state whether your company is a manufacturing company, a supplier company, a consulting company, a regulatory body or a university.  

GAMP D-A-CH Forum Meetings

The GAMP D-A-CH Forum is meeting twice a year. The meeting venue will hop around, member companies will host the meetings.

Special Interest Groups  
GAMP D-A-CH is currently operating three working groups on:

• Automated Testing (status: active)
• CLIN/STAT/S Clinical Trial Related and Statistical Systems (status: active)
• Data Migration / Interfaces (status: active)

The follwing working groups have completed their work or are in the process of completion:

• Aspects of Electronic Records and Signatures (status: closed)
• Validation of Small Manufacturing Devices (status: closed)
• Collaboration between Users and Suppliers to conduct Validation tasks (status: closed)
• Validation of Open Source Software (status: preparation of an article for the journal Pharmaceutical Engineering and of a VDI/VDE guideline)
• Alternative Software Development Models and Methodologies (status: preparation of an article for the journal Pharmaceutical Engineering and of a VDI/VDE guideline)

 
For more information in German language see www.vdi.de/gma/gamp-dach.