Assay Development and Method Validation

Course Description

This course is specifically designed to met the analytical needs of those individuals working within FDA regulated industries. This course is designed for those individuals directly working on assay development, test validation, variation assessment and measurement systems analysis (MSA). It is assumed they come from a variety of backgrounds and disciplines and will be working on a variety of projects. Presentation of the course material is designed for sixteen hours of instruction.


This course is required for all employees who actively work on any aspect of assay, measurement, product and process development where the goal is to improve product and process measurement performance.


DOE is a recommended course prior to taking AD-MSA.

Course Objectives

  1. Design experiments for assay characterization
  2. Design experiments for nonlinear modeling
  3. Design experiments for variation reduction
  4. Evaluate measurement errors and isolate sources of variation
  5. Determine methods to correct systematic errors in instruments and assay methods
  6. Determine inspection and test related errors

Detailed Course Outline

Section I: Statistical Foundations and Variation Assessment

  • Introduction to assay and test development, validation and MSA
  • Review of basic statistics
  • Variation analysis methods
  • Section II: DOEs for Assay Development and Evaluation

  • Assay characterization experiments
  • DOE for variation reduction
  • DOE for robustness
  • DOE for nonlinear characterization
  • Section III: Chemical and Biological Assay Evaluation and Validation Accuracy

  • Precision (Repeatability, Intermediate Precision, Reproducibility)
  • Detection limit
  • Quantitation limit
  • Suitability
  • Linearity
  • Range
  • Specificity
  • Robustness
  • Section IV: MSA for Variables Data (Physical and Destructive)

    MSA terms and definitions
    GR&R procedure and analysis
    Secondary breakdown of repeatability
    Discrimination ratio
    MSA for destructive testing
    MSA studies using fluids
    Calibration, correlation and compensation

    Section V: MSA for Attributes Data (Visual and Mechanical)

    Operational definitions
    Probability of a false alarm
    Probability of a miss
    Escape rate
    Statistical tests for attributes

    Section VI: Multifactor MSA Studies

    Using POV for multiple factor gage studies