PAT

14.06.2007 DECHEMA-Haus, Frankfurt am Main

Process Analytical Technology Workshop

June 14, 2007

Invitation

In 2002 the Food and Drug Administration (FDA) announced a new initiative, Pharmaceutical Current Good Manufacturing Practices for the 21st century to enhance and modernize the regulation for pharmaceutical manufacturing and product quality. Part of this initiative is a discussion paper which was published in 2004: Guidance for Industry PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance.

The FDA encourages the pharmaceutical industry via this guidance to voluntarily develop and implement innovative pharmaceutical development, manufacturing and quality assurance by using process analytical technologies (PATs). PAT is a system to analyse and control pharmaceutical and biologics manufacturing through timely measurement of critical quality and performance attributes to ensure the quality of the final pharmaceutical product.

The reactions of the pharmaceutical industries are still restrained. The discussion still is not completed, which effects on the own processes have to be expected. During the workshop experts will share their expertise with the new PAT approaches on biologics processes.

We are looking forward to welcome you in Frankfurt!

Scientific Committee

H. Tups, Bayer Technology Services GmbH, Leverkusen/D
B. Szperalski, Roche Diagnostics GmbH, Penzberg/D
T. Scheper, University of Hanover/D
D. Sell, DECHEMA e.V., Frankfurt/D