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DIA 2013 49th Annual Meeting
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Implementation of Quality by Design: Progress, Challenges and Opportunities - FDA Perspective
Track : Track 12: Pharmaceutical Quality
Program Code: 379
Date: Wednesday, June 26, 2013
Time: 4:00 PM to 5:30 PM  EST
Location: 153C
CHAIR :
 Christine M. V. Moore, PhD (SPKAGY), Acting Director, Office of New Drug Quality Assessment, OPS, CDER, FDA, United States
SPEAKER (S):
Sarah C. Pope Miksinski, PhD (SCHAGY), Acting Director, Div.2, Office of New Drug Quality Assessment, OPS, CDER, FDA, United States
Susan M. Rosencrance, PhD (SPKAGY), Deputy Director of Chemistry (Acting), Office of Generic Drugs, FDA, United States
Laurie Graham, (SPKAGY), Biologist, Division of Monoclonal Antibodies, OBP, OPS, CDER, FDA, United States
Description
This session will describe the implementation of Quality by Design (QbD) in FDA's Center for Drug Evaluation (CDER). Opportunities will be discussed for application of QbD approaches to support continuous improvement and assurance of product quality.

Session Recording
(Code: 379)
DIA 2013 Attendee:
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This session is a part of:
DIA 2013 Live Learning Center
CON4 Comp Access: Wednesday Online Access Package - June 26, 2013
Handout Online
(Code: 379)
DIA 2013 Attendee:
Attendees Login
  
This session is a part of:
DIA 2013 Live Learning Center
CON4 Comp Access: Wednesday Online Access Package - June 26, 2013
Implementation of Quality by Design: Progress, Challenges and Opportunities - FDA Perspective