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

Conference

AIChE Annual Meeting

Year

2009

Proceeding

2009 Annual Meeting

Group

Comprehensive Quality by Design in Pharmaceutical Development and Manufacture

Type

Oral

Room

Bayou B

Location

Gaylord Opryland Hotel

Time

Tuesday, November 10, 2009 - 3:15pm to 5:45pm

Chair(s)

Chatterjee, S., FDA

Co-chair(s)

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

Presentations

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

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

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

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Pricing

Individuals

2009 Annual Meeting

AIChE Pro Members	$150.00
AIChE Graduate Student Members	Free
AIChE Undergraduate Student Members	Free
AIChE Explorer Members	$225.00
Non-Members	$225.00

Comprehensive Quality by Design in Pharmaceutical Development and Manufacture only

AIChE Pro Members	$100.00
Food, Pharmaceutical & Bioengineering Division Members	Free
AIChE Graduate Student Members	Free
AIChE Undergraduate Student Members	Free
AIChE Explorer Members	$150.00
Non-Members	$150.00