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The Center for Professional Advancement, 90 Minute Accredited Online Training
September 17, 2009 at 11:00 a.m.–12:30 p.m. (ET)
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) and for product developers whose organizations will benefit from Quality by Design (QbD.) The course will help develop synergy between GMP and PAT, enhance risk management and effect incorporation of production efficiency methods such as Six Sigma and LEAN. 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
• Unit operations staff
• Business planners
• Human Resource and Training staff Description
This 90-minute accredited training course knits PAT and QbD concepts into a useful and relatively seamless evolution within your existing quality assurance system. Its modules show how to avoid “throwing the baby out with the bath water” mistakes that have hindered adoption of dynamic process control in quality-based dosage form manufacturing. It also explains the roles of ICH documents Q8, Q9 and Q10 as enhancers of emerging Quality-by-Design product planning.
Module 1:
• PAT and QbD regulatory interaction
• Fitting cGMP into the program
• Defining PAT & QbD program elements
• What outcomes should you expect?
Module 2:
• Process and product-intermediate control: Process
Signatures, Parametric Release
• Examining SOP's for overlap and effectiveness in dynamic
control
• Acceptable risk when using PAT and QbD approaches
• LEAN-Six Sigma: what roles can they play? What should
they contribute?
Module 3:
• Benchmarking and goal establishment
• Detailed guide to the resources that you will need
• Relating results to the “big picture”
• Using Technology Transfer concepts to enhance PAT and
QbD programs
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, 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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salbers@cfpa.com
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