Spec Setting and Stability Analysis using JMP (0.5 days)

Spec Setting and Stability Analysis using JMP (0.5 days): This course provides instruction on how to use JMP statistical software for setting specifications and stability analysis including degradation analysis using the Arrhenius acceleration factor.

Spec Setting and Stability Analysis using JMP Objectives:

• know the recommended approaches for setting specifications
• be able to calculate the range, a reference interval, and tolerance interval
• understand how to adjust a reference interval to account for small sample sizes
• understand the purpose of a stability study
• know the need to evaluate stability dat
• understand the importance for a test of poolability of batches
• be able to use Analysis of Covariance (ANCOVA) is used to evaluate stability data
• be able to use JMP to determine expiries based upon the criteria outlined in the ICH guidance on
  evaluation of stability data
• understand the need for accelerated degradation analysis
• be able to fit a nonlinear function using the Arrhenius acceleration factor

Outline:

1. Setting Specifications
• Min, Max Intervals
• Reference Intervals – Normal Distribution
• Reference Intervals – Non-Normal Distribution (Self Study)
• Tolerance Interval
• Adjusted Reference Intervals for Small Sample Sizes

2. Stability Analysis
• Purpose of stability analysis
• Setting expiries – Situation 1
• Setting expiries – Situation 2
• Setting expiries – Situation 3
• Evaluating accelerated degradation analysis using the Arrhenius acceleration factor
• Evaluating stability for non-linear degradation (self study)