Tunnell Consulting’s Julia O’Neill Presents at Fall Technical Conference

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Session highlights a major shift in discovery of life-changing medicines, and the increasingly important role of statistics in development and manufacturing

"Qualified FDA clinical statisticians are being asked to review manufacturing statistical applications, statisticians from other industries are moving into pharmaceuticals and biotech, and engineers and scientists are building their practical knowledge of applied statistics.”

Tunnell Consulting announced today that Julia O’Neill, a Principal and CMC statistician with over 30 years of experience bridging statistics and chemical engineering, will present at the 61st Annual Fall Technical Conference. This year’s theme for this important meeting is “Statistics: Powering a Revolution in Quality Improvement.” The event will take place from October 4-6, in Philadelphia, Pennsylvania.

Julia’s session, “Saving Lives with Statistics: A Framework for Statistical Applications in Pharmaceutical Manufacturing & Development,” will lead the day on Friday, at 8:00 to 9:30 a.m. The conference, a forum for statistics and quality, is cosponsored by the American Society for Quality (Chemical and Process Industries Division and Statistics Division) and the American Statistical Association (Section on Physical and Engineering Sciences and Section on Quality and Productivity).

In Julia’s session, she will cover the revolution in the approval process for life-changing medicines, and how it has resulted in new products being accelerated through design and validation, and into commercial production. At the same time, expectations for control of pharmaceutical manufacturing have shifted from inspection-based monitoring, to designing quality into the process. “These two forces have driven high demand for the use of statistics throughout development and manufacturing,” said Julia. “As a result, qualified FDA clinical statisticians are being asked to review manufacturing statistical applications, statisticians from other industries are moving into pharmaceuticals and biotech, and engineers and scientists are building their practical knowledge of applied statistics.”

Julia’s presentation will also include discussion of a framework for the application of statistics in the pharmaceutical industry, focusing on the “big picture.” The session will be especially relevant to formally trained statisticians without extensive experience in pharmaceutical manufacturing, and also for scientists and engineers who are interested in applying statistical methods in their work.

About Tunnell Consulting
Founded in 1962 and serving many of the world’s leading life sciences firms and government agencies, Tunnell Consulting, Inc. integrates strategic, technical, process, and organizational skills to design and implement sustainable solutions that exactly meet client needs. With deep industry knowledge, extensive scientific credentials, and superior measurable results, we consistently boost the operating performance of each unique client we serve. To learn more, visit us online at http://www.tunnellconsulting.com.

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