144 QbD: Has It Delivered on the Promises?

Monday, November 4, 2013: 12:30 PM
Plaza A (Hilton)
Description:
QbD – Has it delivered on the promises?

Sponsor:
Pharmaceutical Discovery, Development and Manufacturing Forum

Chair:
Huiquan Wu
Email: huiquan.wu@fda.hhs.gov

Co-Chair:
Jose E. Tabora
Email: jose.tabora@bms.com

- indicates paper has an Extended Abstract file available on CD.


12:30 PM
(144a) Tales From the Trail: A Continuing QbD Journey
John Lepore

12:49 PM
(144b) Quality By Design Pilot to Reality: The Honeymoon Phase
Mary T. Am Ende

1:08 PM
(144c) Quality By Design Pilot To Reality: The Stormy Years
Christine Seymour and Mary T. Am Ende

1:27 PM
(144d) Road to the Promised Land of QbD: Informatics and Modeling Challenges
Venkat Venkatasubramanian
File available
1:46 PM
(144e) Process Understanding in the Context of QbD: Current Approaches and Desired State
Johannes G. Khinast

2:05 PM
(144f) Quality By Design for Drug Substance Development – An Industry Perspective
Srinivas Tummala
File available
2:24 PM
(144g) Quality be Design and Regulatory Science: An Academic Perspective
Henry Y Wang

2:43 PM
(144h) Why Are We So Risk Adverse?
Adam Fermier, James Weber, John Cunningham, Steve Mehrman, Eugene Schaefer, Kris Barnthouse, Alison Harkins, Brett Hanna, Matej Janovjak and Walter Cedeno
See more of this Group/Topical: Pharmaceutical Discovery, Development and Manufacturing Forum
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