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Proceedings
2011 Annual Meeting
Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
QbD Plenary
2011 Annual Meeting
Session: QbD Plenary
Chair
Huiquan Wu
, FDA/CDER/OPS/OTR/DPQR, HFD-940
Co-Chair
Christine Seymour
, Pfizer
Presentations
08:30 AM
Introductory Remarks
08:35 AM
(48a) Quality by Design (QbD) Opportunities, Challenges and Future Direction
Moheb Nasr
09:10 AM
(48b) QbD - It's Not Just for Breakfast Anymore
Paul C. Collins
09:45 AM
(48c) Challenges and Opportunities for Process Systems Engineering Approaches to QbD and Design Space
Gintaras V. Reklaitis
10:20 AM
(48d) Evolution of QbD From a Drug Substance Scientist's Perspective
Timothy J. Watson