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
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