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November General Meeting  

The Golden Bull Restaurant
7 Dalamar Street
Gaithersburg, Maryland  20877

Map to The Golden Bull Restaurant

Nov 19, 2009    6:00 pm - 9:30 pm

 "Question-based Review: A New Quality Evaluation System"

Presented by

David J. Skanchy, Ph.D., LCDR USPHS

Thursday, November 19, 2009
at the
The Golden Bull Restaurant 
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 Arrangements@asq509.org.  Please note:  Meal preferences cannot be guaranteed if one is not registered by Tuesday, November 17, 6:00pm.

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 Arrangements@asq.org to cancel your dinner prior to the event.  Thank you for your cooperation! 

Presentation Summary: The Question Based Review is a new submission and review paradigm that was fully implemented by the Office of Generic Drugs (OGD) in 2007 with the goal of encouraging sponsors to include Quality by Design (QbD) principles in their product and process development and communicate this knowledge in their submissions.  The major objectives of this initiative were to:

  • Assure product quality through product design and performance-based specifications;
  • Facilitate continuous improvement and reduce CMC supplements through risk assessment;
  • Enhance the quality, transparency, and consistency of reviews through standardized review questions;
  • Reduce CMC review time when applicants submit a quality submission that addresses the QbR questions.

This talk will provide an overview of the QbR submission and review process and provide an assessment from the perspective of a chemistry reviewer on how QbR has contributed to improvement in the quality and consistency of reviews and the incorporation of QbD principles into generic submissions.  The assessment is based on the presenter’s experience in reviewing more than twenty QbR applications submitted over the past two years covering various dosage forms, including numerous modified release drug products.

Speaker Biography:  David Skanchy is a Lieutenant Commander in the Public Health Service assigned to the Office of Generic Drugs at FDA.  David started at OGD in 2002 as chemistry reviewer, responsible for performing the Chemistry, Manufacturing, and Controls (Quality) review on generic drug applications and recently moved to a position in the OGD Science Staff under Dr. Lawrence Yu.  As a member of the Science Staff David works on chemistry related issues in Citizen Petitions, official correspondence and guidance to the industry, and the application of Quality by Design principles to the question based chemistry review process (QbR).  Prior to joining FDA, David was an Officer in the United States Army serving in assignments as Deputy Commander of the Forensic Toxicology Drug Testing Laboratory at Ft. Meade (2001 to 2002) and as a research scientist in the Division of Experimental Therapeutics at the Walter Reed Army Institute of Research (1997 to 2001) where he worked on the discovery and pre-clinical development of drugs for the treatment and prophylaxis of malaria.  David received his Ph.D. in Pharmaceutical Chemistry from the University of Kansas in 1996.

For directions to the Golden Bull Restaurant, see the November 2009 General Meeting Announcment.