PTI - international

Agenda: Day Two

• 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• Comply with the FDA's 2004 PAT draft guidance requirements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