January BioMed/BioTech SIG Meeting #2  

"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.

The goal of the FDA’s Quality by Design initiative is to achieve a higher level of quality assurance and process understanding, which in turn may lead to regulatory flexibility.

This initiative is supported by U.S., European, and Japanese regulatory authorities through guidance from the International Committee on Harmonization (ICH Q8, Q9, and Q10).

Location: Kelly's Deli Conference Center, 7519 Standish Place, Rockville, MD 20855

For headcount purpose, please register by Wednesday, January 28, 2009.

To register, click Here  (http://www.asq509.org/ht/d/DoSurvey/i/35080)

For registration problems or further information contact Dr. George Chang, BioMed/Biotech SIG Chair, at gchang2008@yahoo.com or call (240) 793-8425.

Directions: From I-270 (N or S bound):    

Take Exit 9A and exit from the first right exit;

Turn left (east) onto Shady Grove Dr.;

Turn right (south) onto Rockville Pike (Route 355);

Turn left (east) onto East Gude Dr.;

Turn left (north) immediately onto Crabb's Branch Dr.;

Turn left (west) immediately onto Standish Place.

(The first building on your right side is 7519 Standish Place; open parking)

The conference room is on the first floor with its entrance opposite to the left side of building main entrance.