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QA/QC Statistics for Non-Statisticians

Complete Hands-on, "Number Crunching" Analysis of Sample Data Sets!

  • 11/10/2008 - 11/11/2008

    Philadelphia, PA

  • 12/01/2008 - 12/02/2008

    Washington, DC

Agenda: Day One

I. Introduction and Basic Overview of Common Statistical Tools

  • Define types of statistics:
    • descriptive
    • inferential
  • Identify inferential methods:
    • estimation
    • testing
    • confidence intervals
  • Identify basic statistical terms/tools
  • Determine how statistical inference is used in the product development process
  • Discuss applicable software packages for use:
    • Microsoft Excel
    • Mini-tab
    • SAS
    • JMP

Exercise: Identify Participants' Statistical Experience and Course Goals

Exercise: Summary Statistics and Data Presentation

II. Apply Statistics to Specification Setting

  • Set appropriate product specifications
  • Determine FDA requirements for OOS results
  • Determine how to best investigate OOS results
  • Use confidence intervals and tolerance intervals
  • Hypothesis testing:
    • z and t tests

Exercise: Setting Statistical Based Specifications

 III. Implement Design of Experiments (DOE)

  • Design experiments appropriately and effectively
  • Ensure that experiments are reproducible
  • Improve process capability by reducing variability
  • Analysis of variance

Exercise: Mock Experimental Design

IV. Validate Your Testing Methods using Statistics

  • Analyze ICH guidelines (Q2A and Q2B)
  • Ensure robustness and ruggedness of your method
  • Develop protocols based on sound statistical methods
  • Quantity validation characteristics:
    • linearity
    • accuracy
    • percision
    • range
    • limit of detection (LOD)
    • limit of quantitation (LOQ)
  • Regression analysis and variance components
  • Analysis of stability Data

Exercise: Analysis of a Method Validation Study Including Protocol Development

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