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The Center for Professional Advancement, New Brunswick, NJ
April 2-3, 2008
Who Should Attend
This comprehensive quality system workshop will benefit professionals who are involved in managing and operating in the ICH Q8, Q9 and Q10 areas, as well as those who interact with PAT and QbD programs, including:- PAT and QbD Team Leaders and Members
- Quality and Efficiency Personnel
- Manufacturing Operations Personnel
- Product Development Teams
- Technology Transfer Personnel
- In-process and Finished Goods Analysts
- Analytical Instrument and Manufacturing Equipment Suppliers
- Managers tasked with improving pharmaceutical operating efficiency
Description
ICH Q9 is one of the three “cornerstone” guidances proposed by the International Conference on Harmonization and undergoing adoption in The European Union, Japan and the USA. These policies, called Q8, Q9 and Q10, form an international platform that will dramatically improve efficiency and safety within the entire pharmaceutical life cycle. ICH Q8 and Q10 cover drug manufacturing and drug development by treating their individual operating steps as entities that are subject to variance. The platforms aim to reduce stepwise variance so that the likelihood of failure or rejection at the conclusion of the process is minimal. Both use riskmanagement techniques to accomplish their goals.
Risk management involves assessment of pharmaceutical unit operations for critical-to-quality attributes, evaluation of tolerable variance, measurement and control of those parameters and eventually, high release rates with minimal likelihood of recall or patient risk. Putting risk management into practice involves multivariate analysis of all development and production factors.
This course provides both principles and practices for successful ICH Q9 implementation.
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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 and President, Carroll Ventures, Inc.
John E. Carroll, C.Ph.C., Managing Partner, Cadrai Technology Group President; Carroll Ventures, Inc. 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.
Also, Mr. Carroll, as Pharmaceutical Business Unit Manager, for Perstorp Analytical Instruments (now Foss), 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, and is a Certified Pharmaceutical Consultant. He has authored over fifty published papers and is the author of “The NIR Desk Reference” (Carroll, He & Landa) and “The Handbook of FTIR” (Carroll). He is also the editor of “IR-MS: High Sensitivity and Selectivity for Organic Analysis.” (Mattson & Carroll.) His professional affiliations include: American Chemical Society, Society for Applied Spectroscopy, The Coblentz Society, the American Association of Pharmaceutical Scientists and The Council on Near Infrared Spectroscopy.
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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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info@cfpa.com
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