PTI - international

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