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The Center for Professional Advancement, 90 Minute Accredited Online Training
March 3, 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 (PAT) and those who are developing new drugs according to USFDA and EMEA product life cycle initiatives (QbD). The concepts presented in this course can establish a blueprint for QRM team formation, experimental and monitoring tools and wide aspects of applicable drug formulation and dosage forms. It is intended for:
• PAT & QbD team managers
• Tech transfer personnel
• Formulators
• Quality program managers
• New product developers
• Production managers
• Regulatory affairs personnel
• Product financial planners
• Function cross-over personnel
• PAT & QbD team members
• In-process analysts
• Product release analysts
Description
This 90-minute accredited training course provides critical decision-making tools, from dosage form design through predictive operation control to product release and patient use. The three modules include an overall exploration of the current QRM climate, benchmarking tools, selection strategies for new and mature drugs and smooth regulatory interaction.
Module 1:
• Product optimization and life cycle
• Quality Risk Management embraces PAT and QbD
• Birth and death processes of a drug candidate
• Corporate vs. QRM implementers' benchmarks
Module 2:
• Using batch history in the decision process
• Identifying CQA's and CPP's
• Selecting a mature drug product
• Selecting a developmental drug product
Module 3:
• Comparing conventional and QRM life cycles
• Tools for parsing the drug product operation
• Factorial decision-making for product characteristics
• Drug substance influence on the drug product and dosage
form
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, a 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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