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

The below sessions are either SPONSORED or CO-SPONSORED by this Area.

Monday, October 17, 2011

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8:30 AM-11:00 AM


(#48) - TI000 QbD Plenary
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
(#68) - TI012 Application of Quality by Design In Drug Product Process Development I
Sponsored by: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsored by: Pharmaceuticals (15b), Process Research and Innovation (12a)

3:15 PM-5:45 PM


(#138) - TI014 Application of Quality by Design In Drug Product Process Development II
Sponsored by: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture

(#160) - TI011 Implementation of the QbD Paradigm for Packaging Design and Estimation of Product Shelf Life
Sponsored by: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsored by: Pharmaceuticals (15b)

Tuesday, October 18, 2011

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8:30 AM-11:00 AM

Files available
(#202) - TI005 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)

12:30 PM-3:00 PM


(#332) - TI006 QbD In Analytical 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
(#407) - TI002 Round Table Invited Session On QbD: QbD Filings
Sponsored by: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsored by: Pharmaceuticals (15b)

6:30 PM-9:30 PM


(#422) - TI015 Excellence In Integrated QbD Practice
Sponsored by: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsored by: Pharmaceuticals (15b)

Wednesday, October 19, 2011

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8:30 AM-11:00 AM

Files available
(#432) - TI008 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)

12:30 PM-3:00 PM


(#497) - TI009 Applications of Multivariate Data Analysis In Pharmaceutical Process Development: Traditional and Advanced Multivariate Methods
Sponsored by: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture

3:15 PM-5:45 PM

Files available
(#607) - TI007 QbD for Modified Release Dosage Forms
Sponsored by: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsored by: Pharmaceuticals (15b)

Thursday, October 20, 2011

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8:30 AM-11:00 AM

Files available
(#655) - TI001 Integrated QbD Approach for Design Space Development Including Real Time Release
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
(#696) - TI013 Innovations In Biopharmaceutical Processing: Factory of the Future
Sponsored by: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsored by: Pharmaceuticals (15b)

(#701) - TI003 Model Based QbD In Drug Substance or Drug Product 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


(#752) - TI004 QbD In Dry Powder Inhaler Development : Multifaceted Powder Characterization for Product Development
Sponsored by: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsored by: Pharmaceuticals (15b)

(#754) - 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)