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 scientists, engineers and quality professionals who actively work on all aspects of discovery, product and process development where the goal is to characterize, optimize and improve product and process performance.
ESDA and DOE are recommended courses prior to taking PCD-SPC.
- Understand the language and compute the basic statistics associated with SPC.
- Apply the ten process control requirements to achieve process control.
- Determine rational subgroup formation, sample size and frequency.
- Select appropriate control chart for process control requirements.
- Compute appropriate control limits.
- Develop appropriate SPC Charts and associated OCAPs.
- Determine process capability.
- Describe the roles and responsibilities for using SPC.
- Use JMP to analyze process variation patterns, generate SPC charts and determine process capability.
Detailed Course Outline
Section I: Introduction and Basic Statistics
SPC a basis for control
Standard error of the mean
Central limit theorem
Section II: Ten Requirements for Designing Effective Process Control
- Clear product specifications
- Effective metrology
- Process characterization
- Sampling plan
- Control chart selection (variables and attributes)
- Alarms, closing the loop and out-of-control action plans (OCAP)
- Process documentation
- Operator and engineering training
- Routine line audits
Section III: Process Capability
Determining process stability prior to computation of capability
Cp and Cpk
Sigma and z as measures of process capability
Tests for normality
Distribution fitting for nonnormal parameters
Section IV: Process Control Implementation Roles and Responsibilities
Process control specialist