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

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

Chair(s)

Co-chair(s)

Wu, H., FDA

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

Papers

3:15 PM
(325a) A Contemporary Perspective of Design Space Development and Maintenance
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
4:05 PM
(325c) QbD – Design Space Management / Maintenance
4:30 PM
(325d) A Strategy of Using Mechanistic Understanding for Continuous Quality Verification
4:55 PM
(325f) Role of Models for Implementation of Design Space: An FDA View
5:20 PM
(325e) Role of Real-Time Monitoring Tools and Chemometrics for Development and Maintenance of Pharmaceutical Design Space

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Pricing

Individuals

2009 Annual Meeting
AIChE Members $150.00
AIChE Graduate Student Members Free
AIChE Undergraduate Student Members Free
Non-Members $225.00
Comprehensive Quality by Design in Pharmaceutical Development and Manufacture only
AIChE Members $100.00
AIChE Food, Pharmaceutical & Bioengineering Division Members Free
AIChE Graduate Student Members Free
AIChE Undergraduate Student Members Free
Non-Members $150.00

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