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CfPA - The Center for Professional Advancement, 90 Minute Accredited Online Training
September 18, 2013 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend
Quality-by-Design (QbD) is a concept that applies logic to assessing and controlling variance. It is often applied to manufacturing process operations, but its concepts are equally valuable when it is applied to supporting operations such as analytical chemistry, instrumental analysis and line-based process analysis. When doing so, the core QbD elements – Knowledge Base, Risk Management and Design Space – apply. The key to making the concept work is to establish Target Profiles. These profiles serve as the intended limits of the QbD application and also as guides to establishing design experiments. This course provides guidance for establishing, assessing not only those profiles, but the tools used to make them happen. It is intended for:
• QbD project managers
• QbD team members
• Formulation scientists
• Analytical method developers
• Technology transfer specialists
• Personnel concerned with process analysis and control
• Unit operations staff Description
This course will be available On Demand: September 19, 2013
This 90-minute accredited training course will help both analysts and formulators assess uncertainty that stems from instrumental limits, issues of detectability, noise, false signals and reagent contributions to error. With this information, the participant will be able to define a robust analytical target profile for use as a QbD program element. Using parallels to product target profiling in manufacturing-oriented QbD, reagents, excipients and APIs can be coordinated with robust analytical methods to refine overall efficiency.
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Organized by:
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CfPA - The Center for Professional Advancement |
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Invited Speakers:
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John E. Carroll, C.Ph.C., CEO, Carroll Brands, Director, Cadrai Group
John E. Carroll, C.Ph.C., is CEO of Carroll Brands and Director, Cadrai Group. The Cadrai Group develops and presents focused training programs for issues germane to the current needs of the pharmaceutical industry including small-molecule, biologic and nutraceutical preparations. Cadrai has an equally strong focus in both training and business development for the analytical instrument industry. Among Cadrai successes are: ion-mobility spectrometry for cleaning verification, NIR dedicated to tablet & capsule analysis, laser induced breakdown spectroscopy, chemical imaging and automated dissolution.
As Pharmaceutical Business Unit Manager for Perstorp Analytical Instruments (now Foss), Mr. Carroll built a global, sustainable business that saw over 8,000 NIR test instruments placed within the pharmaceutical manufacturing industry.
Mr. Carroll has a B.A.S in Engineering Technology/Chemistry, an M.B.A. (c) in International Marketing, sixty publications and numerous technical presentations. He is the author of “The NIR Desk Reference” (Carroll, He and Landa) and “The Handbook of FTIR” (Carroll). He is also the editor of “IR-MS: High sensitivity and selectivity for organic analysis” (Mattson and Carroll). Professional memberships include AAPS, ACS, CNIRS and ISPE.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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sberg@cfpa.com
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