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Regulatory Relief from PAT and Quality by Design: Does it Truly Exist?*
Wednesday, November 14
7:00 am – 8:15 am
Sunrise Session
ACPE #073-999-07-521-L04
Over the past few years, there has been much discussion on Process Analytical Technologies (PAT) and Quality-by-Design (QbD) principles. This has been due to the science and risk-based approaches the Food and Drug Administration has taken or considered. PAT and QbD have been ‘buzzwords’ in the pharmaceutical industrial community. Many companies have adopted the approaches/principles and many are waiting in the sidelines evaluating what all this means to pharmaceutical development in general. Considerable investments need to be made by the companies to adopt these principles and the overall value (return on investments) still needs to be evaluated and understood. Many companies have successfully implemented PAT applications in their manufacturing processes. However, does the application of these principles and building quality into the product, result in the reduction of testing requirements at the finished product stage, i.e., reduced testing or requirements in final specifications? This sunrise session will address the application of these principles and key questions surrounding them both from an industry and agency viewpoint.
Moderators
Gopi K. Vudathala, Ph.D.
Sanofi Aventis
LaiMing Lee, Ph.D.
U.S. Food and Drug Administration
PAT and QbD Experiences: An Industry Perspective
Mukund "Mike" Yelvigi, Ph.D.
Wyeth Pharmaceuticals
PAT: Where Have We Come and Where Do We Go From Here?
G.K. Raju, Ph.D.
Light Pharma, Inc.
Regulatory Relief Through PAT and QbD: FDA Perspective
Moheb M. Nasr, Ph.D.
U.S. Food and Drug Administration
*Session tentatively scheduled to be recorded.
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