Method Validation Parameters


PVL-1210. This e-Lesson is aimed at personnel who require an overview of method validation in the analytical laboratory, including why it must be performed and the various parameters that must be examined.


  • Category: Analytical Laboratory - Validation

Description

After taking this e-Lesson, you will be able to:

  • Explain the purpose of analytical method validation
  • Explain the difference between Category 1 and Category 2 analyses
  • Define 'Specificity' as it relates to HPLC analysis
  • Explain the difference between the terms 'Accuracy' and 'Precision'
  • Describe how stress testing is done as part of method validation
  • Define the term 'Limit of Detection'
  • Define the term 'Limit of Quantification'


KEYWORDS: Accuracy, Analytical Method, Limit of Detection, Limit of Quantification, Linearity, Precision, Robustness, Sample Stability, Specificity, Standards, Stress Testing, Validation.