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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 Two

V. Apply Statistical Process Control
  • Define Statistical Process Control (SPC)
  • Determine how SPC can be applied to and help your process
  • Identify the benefits of using SPC
  • Trend analysis

Exercise: Review and Critique a Sample SPC Control Chart

VI. Design a Statistically Sound Sampling Plan

  • Define different types of sampling
    • random
    • stratified
    • composite
  • Create and justify your sampling plan
  • Account for sampling and measurement error
  • Determine the relationship between sample size, statistical precision, and statistical power

Exercise: Create a Mock Sampling Plan

VII. Comply with FDA Requirements for Process Analytical Technology (PAT)

  • Define process analytical technologies and identify related tools
  • Identify the role statistics play in the PAT framework  
  • Comply with the FDA's 2004 PAT draft guidance requirements

VIII. Statistically Analyze Annual Product Review (APR) Data 

  • Examine statistical techniques relevant to APRs
  • Use descriptive statistics to present the data
  • Use graphs and plots effectively
  • Interpret statistical data to identify trends and deviations

Exercise: Apply Learned Statistical Techniques to Real-World Data

Discussion: Wrap-up Question and Answer Session

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