Download the full curriculum for Statistical and Analytical courses in PDF format.
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.
Complete curriculum for new product development, manufacturing and business process performance optimization.
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.
- 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.
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)
Section IV: MSA for Variables Data (Physical and Destructive)
MSA terms and definitions
GR&R procedure and analysis
Secondary breakdown of repeatability
MSA for destructive testing
MSA studies using fluids
Calibration, correlation and compensation
Section V: MSA for Attributes Data (Visual and Mechanical)
Probability of a false alarm
Probability of a miss
Statistical tests for attributes