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Pharmaceutical Risk Management Tools: Getting the Most Out of ICH Q9

 
  January 02, 2014  
     
 
CfPA - The Center for Professional Advancement, Amsterdam, The Netherlands
14-15 May 2014


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.

 
 
Organized by: CfPA - The Center for Professional Advancement
Invited Speakers: John E. Carroll, C.Ph.C.; CEO, Carroll Brands, Director, Cadrai Group

John E. Carroll, C.Ph.C., is CEO of Carroll Brands and Director, Cadrai Group. The Cadrai Group develops and presents focused training programs for issues germane to the current needs of the pharmaceutical industry including smallmolecule, 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.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
 
   
 
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