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Enhancing and Defining Analytical Testing using QbD (Quality by Design)

  October 18, 2012  
CfPA - The Center for Professional Advancement, Amsterdam, The Netherlands
20-21 March 2013

Who Should Attend
This QbD course demonstrates the interaction of design space, knowledge basing, good analytical science and risk management with analytical methods, especially those that use modern instruments. It is designed for:

  • Pharmaceutical product developers
  • Formulation scientists
  • Real-time release test personnel
  • Instrumental analysts
  • Quality assurance scientists
  • Product manufacturing managers
  • Laboratory managers
  • Food scientists and managers

The course serves as a detailed overview of QbD, focused on current, state-of-the-art Analytical Methods as the target “Desired State.” The Critical Circle concept – zero-sum proportioning between Knowledge Base, Risk State and Desired State (key QbD aspects,) is applied to three principal instrumental methods. Manufacturing QbD aims at a Product Target Profile (PTP). For analytical methods, the Desired State becomes an Analytical Target Profile (ATP.) Course participants will evaluate both pathways and learn to adjust the Critical Circle accordingly.

The course content also includes a thorough grounding in Risk Management as defined and practiced in ICH Q9. The topics apply equally well to pharmaceutical, cosmetic, nutraceutical and food science applications.

Organized by: CfPA - The Center for Professional Advancement
Invited Speakers: 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 smallmolecule, 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.br>
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.
Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
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