2009 Annual Meeting

Session: Regulatory Aspects of QbD: Development and Maintenance of Design Space (Invited Presentations)

Chair

Sharmista Chatterjee, FDA

Co-Chair

Huiquan Wu, FDA

Presentations

03:15 PM

(325a) A Contemporary Perspective of Design Space Development and Maintenance

James C. Spavins

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

James Cheney, Marc Goeller, Chris Balducci, Lorenz Liesum, Mansoor A. Khan

04:05 PM

(325c) QbD – Design Space Management / Maintenance

T. Kourti

04:30 PM

(325d) A Strategy of Using Mechanistic Understanding for Continuous Quality Verification

San Kiang, Shih-Ying Chang

04:55 PM

(325f) Role of Models for Implementation of Design Space: An FDA View

Sharmista Chatterjee

05:20 PM

(325e) Role of Real-Time Monitoring Tools and Chemometrics for Development and Maintenance of Pharmaceutical Design Space

Huiquan Wu