January General Meeting  

"Quality by Design�

presented by

Dr. Lawrence X. Yu

Thursday, January 21, 2010

At the

The Golden Bull Restaurant
in
Gaithersburg, MD
 
Registration & Networking: 6:00 p.m.
Dinner: 7:00 p.m.
General Announcements: 8:00 p.m.
Program: 8:15 p.m.
Adjourn: 9:15 p.m.

The cost is $15.00 for members and students or $25.00 for non-members.

Please register using the button above or by contacting Mrs. Michele Withnell at (301) 461-2469 or .    Please note:  Meal preferences cannot be guaranteed if one is not registered by Tuesday, January 19, 6:00pm. You may attend the presentation without attending the dinner.

Important Notice: ASQ Section 509 is responsible for the meals for all �No shows� at The Golden Bull Restaurant.  Please help us control our losses by notifying our Arrangements Chair Mrs. Michele Withnell at to cancel your dinner prior to the event.  Thank you for your cooperation!

Program Summary:

Pharmaceutical quality must be built into, not tested into the product. Quality by Design is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. It consists of the following steps:

• Define target product quality profile including identification of critical quality attributes of drug product
• Design and develop product and manufacturing processes
• Identify critical material attributes and process parameters
• Control drug substance, excipient, and manufacturing processes
   

Speaker Biography: 

Dr. Lawrence X. Yu is the Deputy Director for Science at the Office of Generic Drugs, Food and Drug Administration. He is also adjunct Professor of Pharmaceutical Engineering at the University of Michigan and adjunct associate Professor of Pharmaceutical Sciences at the University of Maryland. Prior to joining the FDA, Dr. Yu had worked at Pfizer (Upjohn) and GlaxoWellcome for 8 years. Dr. Yu joined the FDA in 1999 and has served as Team Leader, Deputy Division Director, and Division Director. Dr. Yu�s research interests have centered on the prediction of oral drug delivery and the development of pharmaceutical Quality by Design. His compartmental absorption and transit (CAT) model has laid the foundation for the commercial software, GastroPLUSTM and Simcyp�, which are being widely used in the pharmaceutical industry. Dr. Yu is a fellow and the Section Chair of the American Association of Pharmaceutical Scientists and an Associate Editor of the AAPS Journal. Dr. Yu has authored/co-authored over 150 papers, book chapters, and abstracts, and given over 120 invited presentations. He is a co-editor of the book entitled �Biopharmaceutics Applications in Drug Development�. Dr. Yu is the winner of numerous awards including the American Foundation for Pharmaceutical Education Fellowship, AAPS Excellent Graduate Research, Department of Health and Human Service Outstanding Leadership Award, FDA Commissioner�s Special Citation, Outstanding Achievement, Group Recognition, Regulatory Science, and Team Excellence awards, Upjohn special recognition award, and Naigai Foundation Japan Tokyo Distinguished Lectureship. Dr. Yu received his B. S. in Chemical Engineering from Zhejiang Institute of Technology, his M. S. in Chemical Engineering from Zhejiang University, his M. S. in Pharmaceutics from the University of Cincinnati, and his Ph.D. in Pharmaceutics from the University of Michigan.

DIRECTIONS TO THE GOLDEN BULL

From Rt. 495. Go N. Rt. I-270 (in Maryland). Take Exit 11 off of I-270 East onto Route 124 (Montgomery Village Avenue). Make the first right at the intersection of Route#355 (Frederick Avenue). Go South on Frederick Avenue 0.5 miles. Make right turn onto Dalamar Street to #7 Dalamar Street.

From the intersection of Shady Grove Road and Frederick Avenue (Rt. 355) (in Maryland). Go North on Frederick Avenue about seven miles. Crossover overpass. Continue North to Dalamar Street, and then turn left onto #7 Dalamar Street. Ample parking is available at restaurant.