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The Center for Professional Advancement, 90 Minute Accredited Online Training
November 18, 2008
Who Should Attend
Drug product team managers, anyone involved in PAT, QbD and other efficiency improvement programs, Pharma product life cycle planners, regulatory affairs managers, personnel involved with drug development, formulation, scale-up and drug product management will find this course beneficial. Description
This 90-minute accredited online training will cover the progression of pharmaceutical development as defined in ICH Q8 and its transition into quality management systems. In addition, the course will explore a series of production evaluation, analysis and optimization approaches that will help participants to rank and evaluate quality systems.
Module 1:
Examining the Concept of Risk
• How ICH relates to PAT and QbD
• Risk Identification
• Risk Analysis
• Risk Evaluation
Module 2:
Applying Risk Management
• Risk Assessment Tools
• ICH Q9's Quality Risk Management Process
• To-do Lists
• Using Statistics
Module 3:
Integrating Risk Management with Bio+Pharma Operations
• Basic Risk Management Facilitation Methods
• FMEA-Survey Method
• Fault Tree
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., Managing Partner, Cadrai Technology Group, President, Carroll Ventures, Inc.
John E. Carroll, C.Ph.C. 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 analytical instrument industry, especially regarding Pharmaceutical applications. As Managing Partner for Cadrai LLC., Mr. Carroll modified and introduced ion mobility spectrometers for cleaning verification, an automated fiber optic/UV sensed dissolution apparatus for rapid pharmaceutical product screening and numerous Near-Infrared spectrometric systems for dedicated pharmaceutical applications. All products used proprietary technology of the principal clients.
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, fifty publications and 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).
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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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