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 those individuals that directly work with assay development and method validation. Further it may be helpful for those individuals that work with process characterization and generation of predictive models.
Engineering Statistics and Data Analysis is recommended.
- Determine the best fit for linear models
- Identify when nonlinear models may be appropriate
- Select and fit nonlinear models
- Evaluate and predict performance from nonlinear models
- Evaluate the lack of fit from nonlinear models
- Determine EC50 and relative potency using JMP
Detailed Course Outline
Section I: Basics of Linear Modeling
Section II: Nonlinear Models
Adding X factors
Section III: Bio Assay and Relative Potency
Potency and Relative Potency
JMP Bioassay Addin
Section IV: Nonlinear DOE