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CfPA - The Center for Professional Advancement, 90 Minute Accredited Online Training
September 16, 2013 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend
You are charged with exploring or implementing a QbD effort within your organization. The documents that explain the Quality-by-Design concept devote twenty pages to the aims, goals and expectations of QbD in the Pharma manufacturing industry. Your team is formed, at least on paper. Now what do you do? The QbD core elements; Knowledge Base, Risk Management and Experimentation are in the documents but you need to understand them and make them work within your company and product needs. This course provides a guide to extracting the resources that you will need from your internal operations (knowledge base;) establish and apply metrics that take risk management out of the conceptual framework; and will suggest tools that simplify your experiments. It is intended for:
• QbD project managers
• QbD team members
• New product unit managers
• 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 17, 2013
This 90-minute accredited training course presents methods that assist both QbD team members and process operations personnel in maximizing the value of product history. Risk Priority Number is an extremely useful metric for risk management only when its defining scales are appropriate. This course aids participants in establishing scales that make sense. In its experiment section, the course addresses simplified factorial analysis to reduce the sheer number of experiments, multivariate data analysis and software that will perform these experiments efficiently. At its conclusion, participants will have a toolbox of options for managing the details of a QbD program.
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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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