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January BioMed/BioTech SIG Meeting #2  

Kelly's Deli Conference Center
Next to the entrance to 7519 Standish Drive
FDA/CVM Center
Rockville, Maryland  20855

Jan 29, 2009    6:00 pm - 8:30 pm

"Quality by Design in the Pharmaceutical Industry"

Presented by

Raafat Fahmy, PhD

Science Advisor, Division of Manufacturing Technologies, Office of New Animal Drug Evaluation, Center for Veterinary Medicine, FDA

 Thursday, January 29, 2009

6:00 PM - Networking and Pizza and soft drink with a door prize*
6:30 - 8:30 PM - Program
8:30 PM - Door-prize drawing and networking

* Open and free to the public

Quality by design (QBD) is a systematic approach to drug development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. To achieve quality by design, all critical quality attributes that impact product performance should be identified and controlled in the early stages of development and continue throughout the product lifecycle.