Quality by Design (QbD) is an initiative of the U.S. Food and Drug Administration and the biomedical industries it regulates that is intended to integrate the quality process through research, development, manufacturing and distribution. When properly implemented, QbD improves speed to market; reduces product variation; improves operating efficiency; and reduces costs at all stages of the process. When applied to the automated laboratory, QbD principles provide continuous monitoring of all key variables, allowing scientists and managers to focus attention on the areas of the laboratory operation with the highest level of risk.

Speaker:

Sandy Weinberg, Ph.D.
Associate Professor of Health Care Management, Clayton State University
Senior Consultant, Tunnell Consulting

Sandy Weinberg is an Associate Professor of Health Care Management at Clayton State University in Atlanta, and a Senior Consultant with Tunnell Consulting. Prior to his current position, Sandy headed the Biodefense Project at GE Healthcare, Atlanta, GA, and was the Linnaeus Chair of Biomedical Entrepreneurship, Muhlenberg College, Allentown, PA. The author of numerous professional publications, Sandy possesses over 25 years of regulatory experience, holds several patents, and has served as a consultant for governmental agencies in the US and abroad.

Moderated by:

John Joyce, Ph.D. 
Contributing Editor. Scientific Computing

With a doctorate in analytical chemistry, John comes to SC via a convoluted route. After finishing playing with the 88" variable energy cyclotron at Texas A&M University, he spent 10 years with The Dow Chemical Company, where he ended up in the Analytical Sciences' Instrument Development & Automation Group. He is currently the LIMS manager for the Commonwealth of Virginia's Division of Consolidated Laboratory Services. In addition to writing Scientific Computing's monthly Tips & Techniques column, John also coordinates much of the magazine's LIMS/Laboratory Informatics coverage.

Listen/download podcast (11:19 min)