Assay Development and Method Validation

Course Description:
Assay Development and Method Validation is specifically designed to meet the
analytical needs of people 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 that
attendees 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 16 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.

 

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

  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.

Prerequisites:  Design of Experiments is a recommended prerequisite for this course.

Detailed Course Outline:

Statistical Foundations and Variation Assessment 
Introduction to assay and test development
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
Suitability
Linearity
Range
Specificity
Robustness
                                                     
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  
                                                           
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              
                                              
Multifactor MSA Studies
Using POV for multiple factor gage studies