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

Areas in this Group/Topical

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


Tentative Sessions


Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
TI010 Scale-up of Pharmaceutical Manufacturing Processes: Toward a QbD Approach
Ecevit Bilgili and Mary T. Am Ende


Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
TI000 Model Based Integrated Design of Pharmaceutical Drug Product and Process
Salvador Garcia-Munoz and Nick Sahinidis


Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
TI003 Quality by Design in Generic Drug Development
Zhigang Sun and Yatindra Joshi


Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
TI002 Challenges Facing CMC Organizations in the Changing Business and Regulatory Environment
Shailendra V. Bordawekar and Peter Clark


Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
TI001 Quality-by-Design (QbD) Round Table Discussion Session: An Integrated and Science-Based Approach for Quality by Design (QbD) Implementation in Pharmaceutical Industry
Huiquan Wu and Christine Seymour


Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
TI008 QbD Topical Plenary Session
Paul C. Collins and Shekhar K. Viswanath


Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
TI004 Quality-by-Design (QbD): Techniques for Quality Risk Analysis and Management Over the Product Life Cycle
Huiquan Wu and Luke R. Schenck


Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
TI009 Applications of Multivariate Data Analysis in Pharmaceutical Process Development
Sze Wing Wong and Jose E. Tabora


Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
TI011 Applications of PAT in a Manufacturing Setting
David Unger and Simon D. Fraser


Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
TI006 TI Application of Quality by Design in Drug Product Process Development
Kevin J. Bittorf and John C. Strong


Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
TI005 TI Application of Quality by Design In API Process Development
Kevin D. Seibert and Christine Seymour


Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
TI007 Model Based QbD in Drug Substance or Drug Product
Richard Schild and Nandkishor K. Nere