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Publications
Proceedings
2009 Annual Meeting
Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Regulatory Aspects of QbD: Development and Maintenance of Design Space (Invited Presentations)
2009 Annual Meeting
Session: Regulatory Aspects of QbD: Development and Maintenance of Design Space (Invited Presentations)
Chair
Chatterjee, S.
, FDA
Co-Chair
Wu, H.
, FDA
Presentations
03:15 PM
(325a) A Contemporary Perspective of Design Space Development and Maintenance
Spavins, J. C.
03:40 PM
(325b) The FDA – Novartis CRADA: A Risk-Based and Systems Approach for Quality by Design (QbD) Implementation for An Approved Pharmaceutical Product
Cheney, J.
,
Goeller, M.
,
Balducci, C.
,
Liesum, L.
,
Khan, M. A.
04:05 PM
(325c) QbD – Design Space Management / Maintenance
Kourti, T.
04:30 PM
(325d) A Strategy of Using Mechanistic Understanding for Continuous Quality Verification
Kiang, S.
,
Chang, S.
04:55 PM
(325f) Role of Models for Implementation of Design Space: An FDA View
Chatterjee, S.
05:20 PM
(325e) Role of Real-Time Monitoring Tools and Chemometrics for Development and Maintenance of Pharmaceutical Design Space
Wu, H.
