4 – 5 May 2010

Karlsruhe/Berlin, March, 11th 2010: On May 4th and 5th 2010 Systec & Services will perform a workshop about e-Validation at this years Computer Validation Conference which will take place at the Steigenberger Hotel in Berlin.

New technical and regulatory developments are the reason for new and broader challenges for Computer Software Validation (CSV).

In consequence 2008 the latest GAMP® Giude was released and published in its 5^th version. In addition the required EG GMP Guideline Annex 11 for “computerized systems” is revised as we speak. The draft was published in 2008 and is still under discussion. The final version is expected for this running year.

The aim of the conference is that both inspectors of the sub-group “computerized systems” as well as representatives of the Pharmaceutical Industry will talk about these new challenges and judge the consequences for the Pharmaceutical Industry and its suppliers.

Within three pre-conference workshops and discussion panels those challenges will be considered and discussed. Titus Krauss of Systec & Services together with his colleague Gert-Uwe Steulmann will lead the workshop „Meet the challenges of Validation Documentation with intelligent workflow management solutions” and will moderate the discussions around that topic. There current Validation methods will be compared with new, software-based solutions and their advantages and disadvantages will be considered.

The conference is prepared for responsible functions within the Pharmaceutical Industry its suppliers and services organizations that have to know and implement the current but also future oriented CSV requirements.We are looking forward welcoming you in Berlin!

Please find the complete conference-program here: PDF-Download (400 Kb)
The conference language is German.

Please find more information at www.gmp-navigator.com