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Using Quality by Design to Improve Manufacturing: How Sponsors and CMOs Speed Production and Improve Compliance
The life sciences industries are going through enormous financial changes that are forcing them to do more with less. Mergers, acquisitions, the patent cliff and more are forcing sponsors and CMOs to finds ways to speed up production while still maintaining quality and compliance.
FDA is promoting the use of Quality-by-Design (QbD) as an approach for helping pharmaceutical and biotech companies speed up production, fine-tune continuous manufacturing and improve quality.
QbD is a disciplined and systematic approach for effectively creating and communicating the processes and systems needed to build quality into the product at every stage of production.
This presentation will present a holistic approach to QbD with a focus on how the needed process understanding is developed to enable effective process development, quality improvement and maintain compliant operations.
You will learn:
The concepts and methods involved will be introduced and illustrated with pharmaceutical case studies and examples. Commonly held misconceptions will be addressed and a holistic approach to QbD will be presented.
This course will be of benefit:
From the following companies:
Dr. Ron Snee, Founder and President of Snee Associates, has an outstanding record of leadership in process and organizational improvement in a variety of industries including: pharmaceutical, biotech, clinical diagnostics, chemical, plastics, telecommunications, financial services, newspapers and insurance. Among Ron's other achievements, Dr. Snee is credited with leading the design of the first company-wide continuous improvement curriculum for the global giant E.I. DuPont de Nemours. Ron has more than 25 years’ experience in his field. Ron holds a host of awards and honors, has co-authored 4 books and published more than 200 articles on process improvement, quality, management and statistics. Ron is a recipient of the American Society for Quality's (ASQ) Shewhart Medal, its highest award, and has also received ASQ's Grant Medal for his continuous contributions to quality education and research, the American Statistical Association's Deming Lecture Award, and was elected to the International Academy for Quality.
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