Session: Quality-by-Design (QbD) Round Table Discussion Session: An Integrated and Science-Based Approach for Quality by Design (QbD) Implementation in Pharmaceutical Industry (2010 Annual Meeting)

Description:

As the FDA and the pharmaceutical industry work together to embrace the shift of pharmaceutical quality regulation towards Quality-by-Design (QbD), significant efforts and progress have been made in various CMC areas of pharmaceutical development, scale-up, manufacturing process control, instrumentations, etc. The invited speakers for this session will present real world case examples to share successful experiences and lessons learned, and to discuss challenges and opportunities associated with the implementation of QbD in the pharmaceutical community. An in-depth Q&A following the presentations should stimulate innovative ideas and strategies in the pharmaceutical CMC area.

Sponsor:

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

Co-Sponsor(s):

Pharmaceuticals (15b)

Chair:

Huiquan Wu
Chemical Engineer
FDA
Division of Product Quality Research, HFD-940
LS64 Room 1080
Silver Spring, MD 20993
Phone Number: 301-796-0022
Fax Number: 301-796-9816
Email: huiquan.wu@fda.hhs.gov

Co-Chair:

Christine Seymour
Pfizer
Pfizer Global Research & Development
MS 7040-1208
Groton, CT 06340
Phone Number: 860-686-1011
Email: christine.b.seymour@pfizer.com

Papers:

299a

Question-Based Review for Generic Drugs
Lawrence Yu, FDA CDER

299b

QbD at the Boundary
San Kiang, Bristol-Myers Squibb Company

299c

Implementing Quality by Design (QbD) for New Drug Products - A Regulatory Perspective
Sharmista Chatterjee, FDA

299d

The Heartburn Associated with Implementing Quality by Design Principles
Kevin D. Seibert, Eli Lilly & Co.

299e

Quality by Design and Mechanistic Models of Pharmaceutical Unit Operations
Pavol Rajniak, Merck &Co.; Shane Grosser, Merck &Co.; John Lepore, Merck &Co.; Rey Chern, Merck &Co.; Eric Ahuja, Merck &Co.

299f

Quality-by-Design (QbD): Integration of Real-Time PAT Process Monitoring and off-Line Product Characterization to Explore the Linkage Between a Pharmaceutical Process and Product
Huiquan Wu, FDA; Mansoor A. Khan, Food and Drug Administratin

299g

Quality-by-Design (QbD) Round Table Discussion
Christine Seymour, Pfizer; Huiquan Wu, FDA

See more of this Group/Topical: Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture

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