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The Center for Professional Advancement, An Online Training Format
June 10, 2008 at 11:00 a.m. - 12:30 p.m. (EST–New York time)
Who Should Attend
This course outlines a detailed plan for working with sensor, monitor and instrument vendors; especially system integrators that customize analytical instruments. DQ, or Development Qualification, helps PAT and QbD managers to specify, acquire and deploy “good-science” monitoring in pharmaceutical manufacturing. It is recommended for:- PAT Team managers and members
- QbD implementers
- Quality Risk Managers
- Analytical method developers for process improvement
- PAT-oriented regulatory affairs personnel
- Instrument procurement personnel
Description
This comprehensive 90-minute online training course provides strategies for prioritizing and selecting PAT/QbD sensors, a ranking system to aid in risk/reward judgment and guidelines for establishing a Scope of Work document that will protect your program requirements. Successful completion will help forestall “gray areas” in procurement, delivery and acceptance.
Module 1:
Matching instruments with Critical-to-Quality attributesSelecting instruments to ensure "Desired State"Rating instrumental technologies for manufacturing useCritical software issues
Module 2:
The Attribute & Application HexagonDoes customization make sense?DQ and the Scope of Work documentMilestones and timetables for procurement
Module 3:
Incorporating IQ, OQ and PQ into procurementRegulatory considerationsSensor redundancyInstrument and test acceptance
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Organized by:
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The Center for Professional Advancement |
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Invited Speakers:
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John E. Carroll, C.Ph.C., Managing Partner, Cadrai Technology Group and President, Carroll Ventures, Inc.
John E. Carroll, C.Ph.C. is Managing Partner, Cadrai Technology Group and President, Carroll Ventures, Inc. The Cadrai Technology Group develops and presents focused training programs for issues germane to the current needs of the analytical instrument industry, especially regarding Pharmaceutical applications. As Managing Partner for Cadrai LLC., Mr. Carroll modified and introduced ion mobility spectrometers for cleaning verification, an automated fiber optic/UV sensed dissolution apparatus for rapid pharmaceutical product screening and numerous Near-Infrared spectrometric systems for dedicated pharmaceutical applications. All products used proprietary technology of the principal clients.
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, a M.B.A. (c) in International Marketing, fifty publications and 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).
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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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info@cfpa.com
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