Archived Content


Monday, August 18, 2014

9:00 to 11:30am

9:00 Overview of Operational Excellence Strategies – PAT, QbD, DoE, and Continuous Improvement

ElizabethRebeilElizabeth Rebeil, Associate Director, Operational Excellence, Shire Pharmaceuticals

9:30 Application of QbD Principles and PAT in the Development of a Control Strategy

AmbarishSinghAmbarish K. Singh, Ph.D., Director, Global Regulatory Sciences-CMC, Bristol-Myers Squibb Company

One of the goals of pharmaceutical development is to develop a control strategy that assures that the quality of the product will be maintained throughout the life-cycle of the drug. Such controls are needed irrespective of whether the drug falls into the category of biologics or small molecules. The application of QbD principles and PAT can aid scientists create process knowledge in a systematic way to help develop a control strategy more efficiently. This presentation will discuss key elements of the QbD principles and how these elements, in conjunction with the application of PAT, could help develop a cogent overall control strategy.

10:15 Coffee Break

10:45 Overview of Statistics used in QbD Throughout the Product Lifecycle

 JamesBlackwellJames Blackwell, Ph.D., M.B.A., President, The Windshire Group, LLC

Statistics are increasingly important in our industry due to QbD, lifecycle expectations for process validation, and the need for organizations to better leverage their resources and data. This fast paced short course provides a high level overview of the use of statistics in QbD for those with limited knowledge of statistics. The course will provide a road map so that those individuals can participate more actively on these topics and be able to better critique work plans addressing development and manufacturing needs.

11:30 Close of Short Course



Elizabeth Rebeil, Associate Director, Operational Excellence, Shire Pharmaceuticals
Elizabeth Rebeil is responsible for supporting and management the implementation of Operational Excellence at Shire Pharmaceutical in Lexington MA. Elizabeth continuously seeks to change the culture of the company through a methodical approach to process improvement (new ways of thinking) and solving problems. Elizabeth Rebeil has over 10 years of Continuous Improvement and Project Management experience. Before Shire, Elizabeth worked for Lonza a global leader in Science and for BOSE Corporation as a Regional Continuous Improvement Manager in the Southwest.

She is a MBB train the trainers with Air Academy Associates, has a Master’s degree in Business Administration with several certifications such as Financial for not Controllers, Training Director, Bose Production System (TPS), Continuous Flow, etc. Other past roles include Regional Continuous Improvement Manager at Bose Corporation (SW), Training & Communication at Chamberlain-LiftMaster, Consultant for Becton Dickson, AVENT, Alcatel, Bard, among others. 

Currently Elizabeth is pursuing her Doctorate degree in Business Management and PMP certification. 

Ambarish K. Singh, Ph.D., Director, Global Regulatory Sciences-CMC, Bristol-Myers Squibb Company

Ambarish Singh holds a PhD in Organic Chemistry from the State University of New York at Stony Brook. He served as a post-doctoral fellow at Fox Chase Cancer Center, Philadelphia and Memorial Sloan Kettering Cancer Center, New York.

Dr. Singh started his industrial career by joining the Process Research and Development department of Bristol-Myers Squibb Company and contributed heavily to the chemical process development of numerous commercial products, such as Fungizone, Pravachol, Taxol and Baraclude. He has led several successful "start-ups" to transfer laboratory processes to manufacturing sites in Ireland, Italy and Puerto Rico. Ambarish has also led a cross-functional team responsible for developing, manufacturing and filing of the marketing application for Onglyza, a DPP4 inhibitor for the treatment of Type II diabetes.

In 2007, Ambarish transitioned into Global Regulatory Sciences-Chemistry, Manufacturing and Control (CMC) department, where he is a director and responsible for providing regulatory-CMC guidance and strategies for projects that are in development. He has interacted with FDA, EMA, Health-Canada and TGA on CMC filing strategies related to QbD/PAT/RTRt.

Ambarish has received several BMS awards (President’s award, Triumph award, Ondetti & Cushman award) for his contributions to the advancement of Science and Technology in Process R&D. He has published >25 scientific articles and holds 6 patents. External to BMS, Ambarish has given several talks on topics related to chemical process development and QbD/PAT/RTRt at universities and conferences. He has served on the scientific advisory board of the Cambridge Healthtech Institute (CHI) and American Chemical Society local chapter-Regulatory-CMC.

James Blackwell, Ph.D., M.B.A., President, The Windshire Group, LLC

Dr. James Blackwell is a leading industry consultant and President of The Windshire Group, LLC, a global CMC consulting firm. His experience encompasses early process development to commercial operations, and has consulted to clients globally from start-ups to multi-nationals, and to major industry investors. He has been a frequent invited speaker at industry conferences and has contributed to various industry publications. He has held senior positions with Repligen, Genzyme, and Abbott (Abbvie). He served on the formative management team and led Manufacturing and Technical Operations for Shore Therapeutics in the successful re-commercialization of Fenoglide. As a member of ISPE, he has held leadership positions at the Chapter and National levels. Dr. Blackwell has graduate training in chemical engineering, microbiology, and business/technology management from Northeastern University, The Ohio State University, and the University of Maryland, respectively.


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