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The Center for Professional Advancement, 90 Minute Accredited Online Training
May 7, 2009 at 11:00 a.m. - 12:30 p.m. (EST)
Who Should Attend
This course is intended to help pharmaceutical industry professionals charged with enhancing and improving manufacturing efficiency for existing drug products by using Process Analytical Technology (PAT). US FDA and EMEA guidance documents recommend critical evaluation of both process and product parameters, using multivariate analysis. The Design Space focus uses historical batch data and the scientific approach to convert “knowledge space” to “control space”. Design Space is a foundation for Design of Experiment and Desired State. It is intended for:
• PAT & QbD team members
• Quality program managers
• Regulatory affairs personnel
• In-process analysts
• Human Resource and Training staff
• Tech transfer personnel
• New product developers
• Product financial planners
• Product release analysts
• Formulators
• Production managers
• Function cross-over personnel
• Operation personnel
Description
This 90-minute accredited training course provides the tools for identification of drug product and process variables using elements of risk assessment. It establishes a pathway for ensuring drug product quality by setting limits for consistency - in both materials and operations. Design Space principles become invaluable for improving both formulation decisions and scale-up exercises. The course also serves as a foundation for experimental design.
Module 1:
• Examining and mining batch history
• Identifying CQA's and CPP's
• Tools for product and process optimization
• Understanding RPN: The Risk Prioritization Number
Module 2:
• Analytical software for design space applications
• Using CQA's and CPP's to develop control limits
• Process robustness and repeatability: avoiding skewed
controls
• Cyclic examination of results: Make it better!
Module 3:
• Using RPN for developing control schemes
• What goes into “control space?”
• Identify independent and dependent variables
• Which unit operations are preferred targets for control?
Question and Answer Session
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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., President, Carroll Ventures, Inc., Managing Partner, Cadrai Technology Group
John E. Carroll 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 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, laserinduced 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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salbers@cfpa.com
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