2010 Annual Meeting

Group: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture

Chairs

Shekhar K. Viswanath, Eli Lilly & Co.

Christine Seymour, Pfizer

Areas

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

Sessions

November 08, 2010

08:30 AM to 11:00 AM

Scale-up of Pharmaceutical Manufacturing Processes: Toward a QbD Approach

12:30 PM to 03:00 PM

Model Based Integrated Design of Pharmaceutical Drug Product and Process

03:15 PM to 05:45 PM

Quality by Design in Generic Drug Development

November 09, 2010

08:30 AM to 11:00 AM

Challenges Facing CMC Organizations in the Changing Business and Regulatory Environment

12:30 PM to 03:00 PM

Quality-by-Design (QbD) Round Table Discussion Session: An Integrated and Science-Based Approach for Quality by Design (QbD) Implementation in Pharmaceutical Industry

03:15 PM to 05:45 PM

QbD Topical Plenary Session

November 10, 2010

08:30 AM to 11:00 AM

Quality-by-Design (QbD): Techniques for Quality Risk Analysis and Management Over the Product Life Cycle

12:30 PM to 03:00 PM

Applications of Multivariate Data Analysis in Pharmaceutical Process Development

03:15 PM to 05:45 PM

Applications of PAT in a Manufacturing Setting

November 11, 2010

08:30 AM to 11:00 AM

TI Application of Quality by Design in Drug Product Process Development

12:30 PM to 03:00 PM

TI Application of Quality by Design In API Process Development

03:15 PM to 05:45 PM

Model Based QbD in Drug Substance or Drug Product