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QbD Topical Conference Plenary Session: Keynote Addresses

Monday, November 9, 2009: 8:30 AM
Hermitage D (Gaylord Opryland Hotel)

Description:
A collection of talks focused on important gaps to be scientifically addressed for a comprehensive QbD discussion


Sponsor:
Topical I: Comprehensive Quality by Design to Develop and Manufacture Pharmaceutical Products
Co-Sponsor(s):
Systems and Process Design (10a), Process Development Division (12), Pharmaceuticals (15b)


Chair:
Christine M.V. Moore
Email: christine.moore@fda.hhs.gov

Co-Chair:
Kevin D. Seibert
Email: seibertkd@lilly.com


8:30 AM
(52a) Progress in Implementation of Quality by Design - An FDA Perspective
Christine M.V. Moore

9:07 AM
(52b) The Evolution of Quality by Design in Drug Substance Development
John Lepore

9:44 AM
(52c) Drug Product Quality by Design: An Industrial Perspective
Mary T. am Ende

10:21 AM
(52d) Analysis of Electrical Properties of a Powder Blend and Their Effect On Flow Behavior - a QbD Approach
Fernando J. Muzzio
See more of this Group/Topical: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture