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

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
Review Chemist
CDER/FDA
ONDQA (Office of New Drug Quality Assessment)
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone Number: 301-796-2252
Fax Number: 301-796-9850
Email: sharmista.chatterjee@fda.hhs.gov

Co-Chair:

Huiquan Wu

Papers:

325a

A Contemporary Perspective of Design Space Development and Maintenance
James C. Spavins, Pfizer Inc

325b

The FDA – Novartis CRADA: A Risk-Based and Systems Approach for Quality by Design (QbD) Implementation for An Approved Pharmaceutical Product
James Cheney, Novartis Pharmaceuticals Corporation; Mansoor A. Khan, Food and Drug Administratin; Marc Goeller, Novartis; Chris Balducci, Novartis Pharmaceuticals Corporation; Lorenz Liesum, Novartis Pharmaceuticals Corporation

325c

QbD – Design Space Management / Maintenance
T. Kourti, GlaxoSmithKline and McMaster University

325d

A Strategy of Using Mechanistic Understanding for Continuous Quality Verification
Wei Chen, Bristol Myers Squibb; San Kiang, Bristol-Myers Squibb Co.; Shih-Ying Chang, Bristol-Myers Squibb Company

325f

Role of Models for Implementation of Design Space: An FDA View
Sharmista Chatterjee, FDA

325e

Role of Real-Time Monitoring Tools and Chemometrics for Development and Maintenance of Pharmaceutical Design Space
Huiquan Wu, FDA

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

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