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ICH Q9: Managing Risk in Pharmaceutical Manufacturing

 
  June 22, 2007  
     
 
The Center for Professional Advancement, Your Computer - An Online Training Format
July 24, 2007


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 manufacturing.


Description:

Module 1:
The first module covers the progression of pharmaceutical development as defined in ICH Q8 and its transition into quality management systems through these topics:

An overview of the Q8-Q9-Q10 Best Practice flow
Changes in testing practices from production GMP to critical-path QbD
Development of practical steps to institute Risk Management and Risk Reduction


Module 2:
The second module explores a series of production evaluation, analysis and optimization approaches. The material in this module helps participants to rank and evaluate quality systems, including:
Root cause analysis and fault tree logic for decisionmaking
Metrics that help optimize multivariate testing
Quality programs such as FMEA, HACCP and their integration



Course Type: An Online Training Course

 
 
Organized by: The Center for Professional Advancement
Invited Speakers: Please click here for speaker information.
 
Deadline for Abstracts: not applicable
 
Registration: Please click here for registration information.
E-mail: info@cfpa.com
 
   
 
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