Session: Qbd Topical Conference Plenary Session: Emerging Topics (2009 Annual Meeting)

Description:

to be added

Sponsor:

Topical I: Comprehensive Quality by Design to Develop and Manufacture Pharmaceutical Products

Chair:

Salvador Garcia-Munoz
Principal Scientist
Pfizer Global Research and Development
Process Modeling & Engineering Technology
445 Eastern Point Rd.
Groton, CT 06340
Phone Number: 860-715-0578
Fax Number: 860-686-6380
Email: Salvador.Garcia-Munoz@pfizer.com

Co-Chair:

Christine Seymour

Papers:

382a

Drug Substance Scale and Equipment Assessments Linking a Design Space to a Manufacturing Facility: Case Studies
Timothy J. Watson, Pfizer, Inc

382b

The Role of Automatic Process Control In QbD
Richard D. Braatz, University of Illinois at Urbana-Champaign

382c

NIPTE-FDA Collaborative Case Study On Model-Based Design Space Development Across Scales and with Stability Considerations
Gintaras V. Reklaitis, Purdue University; Hamid Arastoopour, Illinois Institute of Technology; Robin Bogner, University of Connecticut; James K. Drennen III, Duquesne University; Lee E. Kirsch, The University of Iowa; James Litster, Purdue University; Eric J. Munson, University of Kansas; Fernando Muzzio, Rutgers University; Raj Suryanarayanan, University of Minnesota; Stephen W. Hoag, University of Maryland; Mansoor A. Khan, Food and Drug Administration

382d

QbD and Statistics: What a Chemical Engineer Needs to Know
David Christopher, Schering-Plough Research Inst

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

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