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The Center for Professional Advancement, 90 Minute Accredited Online Training
May 21, 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.) Based on USFDA and EMEA guidance documents , this course helps the user to establish a pathway to consistently high product quality. The Design-of-Experiment focus uses factorial and multivariate analysis and arithmetic process benchmarks for SPC and EVOP control. Design-of-Experiment is an integral element of Design Space and Desired State. It is intended for:
• PAT & QbD team members
• Tech transfer personnel
• Formulators
• Quality program managers
• New product developers
• Production managers
• Regulatory affairs personnel
• Product financial planners
• Function cross-over personnel
• In-process analysts
• Product release analysts
• Operation personnel
• Human Resource and training staff
Description
This 90-minute accredited online training course helps convert design space principles to a robust operating plan. By applying measurable factors such as process capability index and process vs. product sigma, the course serves as a “how to” guide for converting knowledge space into useable control elements, especially for SPC programs. The course also serves as a foundation for establishing “desired state”.
Module 1:
• Selecting your future control parameters
• Reducing the variables to a manageable few
• Applying multivariate statistics as “filters”
• Parameter detectability
Module 2:
• Partitioning the process study: Team Dynamics
• Establishing upper and lower control limits
• Cpk and Sigma
• What tools are available in ICH Q8R, Q9 and Q10?
Module 3:
• Awareness of “shadow variables”
• Simplify, simplify and then, simplify
• Using the control factors for “process signatures”
• Using process signatures and specifications for eventual
real-time release
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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