Session: Plenary Session - The Next Frontier in the Application of Quality by Design (2012 Annual Meeting)

Description:

Plenary session on Quality by Design. Invited speakers will address potential new opportunities and challenges in the application of QbD.

Sponsor:

Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture

Co-Sponsor(s):

Computing Systems and Technology Division (10), Food, Pharmaceutical & Bioengineering Division (15), Research and New Technology Committee (18j), Process Development Division (12)

Chair:

Salvador García-Muñoz
Senior Principal Scientist
Pfizer Worldwide R&D
Process Modeling and Engineering Technology
445 Eastern Point Road
Groton, CT 06340
Phone Number: 1 860 715 0578
Fax Number: 860-686-6380
Email: Salvador.Garcia-Munoz@pfizer.com

Co-Chair:

Huiquan Wu
Chemical Engineer
FDA
Division of Product Quality Research, HFD-940
LS64 Room 1080
Silver Spring, MD 20993
Fax Number: 301-443-5225
Email: wuh@cder.fda.gov

Papers:

43a

Looking to the Future in Continuous Pharmaceutical Manufacturing
Richard D. Braatz, Massachusetts Institute of Technology

43b

New Challenges and Opportunities for Pharmaceutical Manufacturing Science
Vincent Vilker, FDA; Mansoor A. Khan, Food and Drug Administratin

43c

Recent Advances in the Molecular Modeling Foundation of Systems-Based Pharmaceutics
Constantinos C. Pantelides, Imperial College London,Center for Process Systems Engineering

43d

Experience with Regulatory Issues for Biomedical Devices and Vision for the Use of Advanced Control In Pharmaceutical Operations
Francis J. Doyle III, UCSB; Eyal Dassau, UCSB; Howard Zisser, Sansum Diabetes Research Institute

43e

Chemical Engineering and Biopharmaceutics: Linking the Process with the Ultimate Quality Attribute
Ravi M. Shanker, Pfizer Worldwide R&D

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

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