Assay Development and Method Validation

Course Description

This course is specifically designed to meet the analytical needs of those individuals working within FDA regulated industries. This course is designed for those individuals 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 projects.


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.


Design of Experiments is a recommended course prior to AD-MSA.

16 Hours

Contact Information


1 (650) 967-2700

P.O. Box 2103
Sunnyvale, CA 94087-0103

Course Objectives

Upon completion of the course the participants will be able to:

  • Design experiments for assay characterization
  • Design experiments for nonlinear modeling
  • Design experiments for variation reduction
  • Evaluate measurement errors and isolate sources of variation
  • Determine methods to correct systematic errors in instruments and assay methods
  • Determine inspection and test related errors

Course Outline:

Statistical Foundations and Variation Assessment
Introduction to assay and test development, validation and MSA
Review of basic statistics variation analysis methods

DOEs for Assay Development and Evaluation
Assay characterization experiments
DOE for variation reduction
DOE for robustness
DOE for nonlinear characterization

Chemical and Biological Assay Evaluation and Validation Accuracy
Precision (Repeatability, Intermediate Precision, Reproducibility)
Detection limit
Quantitation limit

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

MSA for Attributes Data (Visual and Mechanical)
Operational definitions
Probability of a false alarm
Probability of a miss
Escape rate
Statistical tests for attributes