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.
There are no prerequisites for this course.
- Determine gage capability.
- Assess accuracy, linearity, stability, repeatability and reproducibility in test equipment.
- Design and deploy SPC for measurement control.
- Select and establish standards.
- Describe proper methods for instrument calibration and compensation.
- Conduct gage capability for inspection activities.
- Discuss how MSA impacts customer satisfaction.
Detailed Course Outline
Section I: Introduction to MSA
MSA is a key to systematic product development
Background statistical principles
Sources of error
Focus on the measurement process
Section II: Terms and Definitions
Section III: R&R, Linearity, & Accuracy
2 factor crossed design for Variables MSA
Repeatability and Reproducibility
R&R and Capability Example
Section IV: Correlation, Calibration and Compensation
Correlation and compensation
Soft compensation versus standard calibration
Problems with r2
Section V: SPC for Measurement Control
Selection and utilization of Standards
SPC for Measurement Control
SPC using stable standards
SPC using unstable standards