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

- indicates session contains Extended Abstract(s) available on CD.

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


Monday, November 8, 2010

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8:30 AM-11:00 AM


(#51) - TI010 Scale-up of Pharmaceutical Manufacturing Processes: Toward a QbD Approach
Sponsored by: Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsored by: Pharmaceuticals (15b)

12:30 PM-3:00 PM


(#108) - TI000 Model Based Integrated Design of Pharmaceutical Drug Product and Process
Sponsored by: Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsored by: Systems and Process Design (10A), Pharmaceuticals (15b)

3:15 PM-5:45 PM

Files available
(#170) - TI003 Quality by Design in Generic Drug Development
Sponsored by: Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsored by: Pharmaceuticals (15b)

Tuesday, November 9, 2010

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8:30 AM-11:00 AM


(#209) - TI002 Challenges Facing CMC Organizations in the Changing Business and Regulatory Environment
Sponsored by: Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsored by: Pharmaceuticals (15b)

12:30 PM-3:00 PM


(#299) - TI001 Quality-by-Design (QbD) Round Table Discussion Session: An Integrated and Science-Based Approach for Quality by Design (QbD) Implementation in Pharmaceutical Industry
Sponsored by: Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsored by: Pharmaceuticals (15b)

3:15 PM-5:45 PM

Files available
(#358) - TI008 QbD Topical Plenary Session
Sponsored by: Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsored by: Pharmaceuticals (15b)

Wednesday, November 10, 2010

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8:30 AM-11:00 AM


(#424) - TI004 Quality-by-Design (QbD): Techniques for Quality Risk Analysis and Management Over the Product Life Cycle
Sponsored by: Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsored by: Pharmaceuticals (15b)

12:30 PM-3:00 PM

Files available
(#445) - TI009 Applications of Multivariate Data Analysis in Pharmaceutical Process Development
Sponsored by: Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsored by: Pharmaceuticals (15b)

3:15 PM-5:45 PM


(#510) - TI011 Applications of PAT in a Manufacturing Setting
Sponsored by: Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsored by: Pharmaceuticals (15b)

Thursday, November 11, 2010

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8:30 AM-11:00 AM

Files available
(#621) - TI006 TI Application of Quality by Design in Drug Product Process Development
Sponsored by: Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsored by: Pharmaceuticals (15b)

12:30 PM-3:00 PM


(#673) - TI005 TI Application of Quality by Design In API Process Development
Sponsored by: Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsored by: Pharmaceuticals (15b)

3:15 PM-5:45 PM

Files available
(#697) - TI007 Model Based QbD in Drug Substance or Drug Product
Sponsored by: Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsored by: Pharmaceuticals (15b)