The Bioprocessing Summit
The Bioprocessing Summit

CONFERENCE SERIES: Bioprocessing & Manufacturing


Digital Course: Operational Excellence in Bioprocessing - PAT, QbD, DoE, and Continuous Improvement


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About this Product: 

Ensuring quality in bioprocesses that complies with regulatory requirements and mitigates risk often results in very high bottom-line costs. Adopting best practices early in the development process and customizing these approaches to operational excellence from other highly competitive industries are currently taking place in biopharmaceutical production. This course provides both an overview of these approaches along with details about how they work, as well as case studies and data addressing how these innovations have been applied successfully in bioprocessing and the development of biopharmaceuticals. Appropriate regulatory guidance is also discussed.

The strategies covered in this Course:

  • Quality by Design (QbD)
  • Design of Experiment (DoE)
  • Process Analytical Technology (PAT)
  • Continuous Improvement
  • Lean Manufacturing
  • Six Sigma
  • The Use of Statistics



Product Details:
3 Presentations
84 Slides
Total Run Time: 1:38:10
Digital Download: $345.00
Single Copy: $345.00
Site License: $1380.00

Formats Available:
Digital Download
On Demand 


Agenda at a Glance: 

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

Elizabeth Rebeil, Associate Director, Operational Excellence, Shire Pharmaceuticals

Increasingly, bioprocesses are drawing on Operational Excellence strategies to optimize output and increase quality. This presentation provides an overview of the strategies, how they work, and how they are being applied in the industry to support bioprocess advances.

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

Ambarish 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.

Overview of Statistics used in QbD Throughout the Product Lifecycle

James 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.

Speaker Biographies: 

 ElizabethRebeilElizabeth Rebeil, Associate Director, Operational Excellence, Shire Pharmaceuticals

Elizabeth Rebeil is responsible for supporting and managing the implementation of Operational Excellence strategies at Shire Pharmaceuticals  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 Life 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 non 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, and Bard, among others.

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

 AmbarishSinghAmbarish 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.

 JamesBlackwellJames 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.

About the Conference: 

The Bioprocessing Summit brings together international leaders to discuss today’s bioprocess issues from cell line selection to bioproduction. The Summit provides practical details in a relaxed, congenial atmosphere that promotes information exchange and networking.

This leading bioprocess meeting is hosted in Boston each summer along the lively and cosmopolitan harbor waterfront. Hundreds of bioprocess professionals come together each year at the Summit to share practical solutions for today’s bioprocess challenges with researchers from around the world.

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