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.

Attendees

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.

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Prerequisites

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
Bias
Linearity
MSA for destructive testing
MSA studies using fluids
Calibration, correlation and compensation

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

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

Section VI: Multifactor MSA Studies

Using POV for multiple factor gage studies