Session: Quality-by-Design (QbD): Techniques for Quality Risk Analysis and Management Over the Product Life Cycle (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), a significant effort was made in the aspect of introducing a risk-based approach to pharmaceutical quality paradigm. The session will feature both invited and submitted papers presenting real world case examples on quality risk management over the product life cycle. Talks providing case studies successful experiences, and lessons learned, and to discuss the benefits and challenges associated with applying risk management principles over the product life cycle in the pharmaceutical community are targeted.

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:

Luke R. Schenck
Merck & Co. Inc.
Pharmaceutical Commercialization Technology
770 Sumneytown Pike
West Point, PA 19486
Phone Number: 215-652-5368
Fax Number: 215-652-2821
Email: luke_schenck@merck.com

Papers:

424a

A Quality Systems Approach to the Product Quality Risk Management Lifecycle
Steven Wolfgang, FDA Center for Drug Evaluation and Research

424b

Implementation of a Normalization Risk Assessment Tool to Link Design Space Inputs
Diana S. Hou, Merck & Co.; Neil MacPhail, Merck & Co.; Edward J. Smith, Merck & Co.; Jennifer Ho, Merck & Co.; Alanna Cleary, Merck & Co.

424c

Risk Based Roadmap for the Approval of Biosimilar Biologics
Henry Y. Wang, University of Michigan

424d

An Example of Quality Risk Management Over Product Lifecycle
T. Kourti, GlaxoSmithKline

424e

Quality by Design in Generic Drug Development: Process Development and Quality Risk Management
Sivakumar R. Vaithiyalingam, Office of Generic Drugs, Center for Drug Evaluation and Research, FDA

424f

A High Throughput, Parallel, Microscale, Fully Automated Approach to Biologics Formulation Development and Stress Test Studies
Eric Carlson, Freeslate Inc; Byeong Chang, Integrity, Bio Inc.; Steve Cypes, Freeslate Inc; Steve Lambert, Freeslate Inc

424g

CFD Simulations for Scale up of Wet Milling in High Shear Mixers
Meng Yang, University of Maryland; Richard V. Calabrese, University of Maryland

424h

Optimizing and Controlling High Value Processes Using the Principles of Quality-by-Design (QbD) Advanced Tools Such as Real-Time in-Situ Particle Characterization, in-Situ Mid-Infrared Spectrometry, and Reaction Calorimetry
Leen Schellekens, Mettler-Toledo AutoChem, Inc.; Des O'Grady, Mettler-Toledo AutoChem, Inc.; Jeffrey Sherman, Mettler-Toledo AutoChem, Inc.

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

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