Assay Development and Method Validation
Biotech, Pharmaceutical and Medical Device
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.

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Download the full curriculum for Statistical and Analytical courses in PDF format.

Biotech, Pharmaceutical & Medical Device Courses

Systematic product development, Quality by Design courses, consulting services and analytical training for biotechnology, pharmaceutical and medical device industries. QbD provides guidance to facilitate design of products and processes that maximize the product’s efficacy and safety profile while enhancing product manufacturability and control.

Lean Six Sigma

Complete curriculum for new product development, manufacturing and business process performance optimization.

Tools & Templates

Development tools and templates created by Thomas A. Little Consulting have been used by numerous companies to aid and support various aspects of product development, problem solving, data analysis and risk assessment.

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 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