Robust Optimization, Design Space and Tolerance Design
Biotech, Pharmaceutical and Medical Device
This course is specifically designed to meet the analytical needs of those individuals working within FDA regulated industries. Robust optimization and tolerance design presents the methods and practices associated with designing and optimizing products and processes. Tolerance design methods to protect product quality and clinical benefits are discussed. The course requires 16 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 scientists, engineers and quality professionals who actively work on all aspects of discovery, product and ROTD.
ESDA and DOE are recommended prerequisites.
Course Objectives
  1. Learn and apply the principles of robust product design.
  2. Design experiments appropriate for the information of interest.
  3. Use and apply the structures of orthogonal arrays for product and process development and problem solving.
  4. Ensure the experimental design is efficient.
  5. Use regression techniques in order to analyze the results and make process/product improvements.
  6. Optimize the response at its most robust condition.
  7. Tolerance the factors and responses.
  8. Use JMP software to design and analyze experiments.
Detailed Course Outline
Section I: Distribution and tolerance design foundations
System, parameter and tolerance design
Tolerance design methods
Section II: DOE review and robust design principles
Eight robust design principles
Section III: DOE using custom designs
Custom designs
Strategies to minimize experimental size
Adding covariate and uncontrolled factors
Special topics for custom designs (optional)
Blocking designs
Setting constraints in the design
Section IV: Robust optimization methods
Tighten the tolerance of X Design to the flats Use interactions to tune out sensitivities Use parameter combinations
Section V: Tolerance design and margin analysis
Tolerance design procedure Tolerance stack up analysis