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

The below sessions are either SPONSORED or CO-SPONSORED by this Area.
- indicates session contains Extended Abstract(s) available on CD.

Monday, October 29, 2012

8:30 AM-11:00 AM

Files available
(#43) - Plenary Session - The Next Frontier in the Application of Quality by Design
Sponsored by: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsored by: Computing Systems and Technology Division (10), Food, Pharmaceutical & Bioengineering Division (15), Research and New Technology Committee (18j), Process Development Division (12)

12:30 PM-3:00 PM

Files available
(#99) - 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: Systems and Process Design (10A)

3:15 PM-5:45 PM


(#146) - Integrated Model Based Design of Pharmaceutical Product and Process
Sponsored by: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsored by: Computing Systems and Technology Division (10), Process Development Division (12)

6:30 PM-9:30 PM


(#182) - Awards Ceremony On Comprehensive Quality by Design
Sponsored by: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture

Tuesday, October 30, 2012

8:30 AM-11:00 AM


(#189) - Application of Multivariate Analysis in Supporting QbD
Sponsored by: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsored by: Applied Mathematics and Numerical Analysis (10D)

12:30 PM-3:00 PM


(#310) - Scale-up of Pharmaceutical Manufacturing Processes - A QbD Approach
Sponsored by: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsored by: Systems and Process Design (10A)

3:15 PM-5:45 PM


(#375) - QbD Round Table - Invited Speakers
Sponsored by: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture

Wednesday, October 31, 2012

8:30 AM-11:00 AM

Files available
(#401) - Application of PAT in the Manufacturing Setting
Sponsored by: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsored by: Systems and Process Control (10B)

(#445) - Process Design I
Sponsored by: Systems and Process Design
Co-Sponsored by: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture (TI)

12:30 PM-3:00 PM

Files available
(#466) - 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: Process Development Division (12)

3:15 PM-5:45 PM

Files available
(#533) - 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: Process Development Division (12)

Thursday, November 1, 2012

8:30 AM-11:00 AM

Files available
(#645) - Materials Characterization
Sponsored by: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture

12:30 PM-3:00 PM

Files available
(#717) - QbD for Drug Release From Pharmaceutical Dosage Forms
Sponsored by: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture