Session: Regulatory Aspects of QbD: Development and Maintenance of Design Space (Invited Presentations) (2009 Annual Meeting)

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

Tuesday, November 10, 2009: 3:15 PM

Bayou B (Gaylord Opryland Hotel)

Description:

This session invites talks that focus on science and risk based approaches for management/maintenance of design space

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:

Sharmista Chatterjee
Email: sharmista.chatterjee@fda.hhs.gov

Co-Chair:

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

3:15 PM

(325a) A Contemporary Perspective of Design Space Development and Maintenance
James C. Spavins

3:40 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, Mansoor A. Khan, Marc Goeller, Chris Balducci and Lorenz Liesum

4:05 PM

(325c) QbD – Design Space Management / Maintenance
T. Kourti

4:30 PM

(325d) A Strategy of Using Mechanistic Understanding for Continuous Quality Verification
Wei Chen, San Kiang and Shih-Ying Chang

4:55 PM

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

5:20 PM

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

See more of this Group/Topical: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture