Root Cause Analysis and CAPA
Biotech, Pharmaceutical and Medical Device
This course is specifically designed to meet the analytical needs of those individuals working within FDA regulated industries. This course is designed for those individuals working directly on product and process development and corrective/preventative action. It is assumed they come from a variety of backgrounds and disciplines and will be working on a variety of process improvement areas across the company. The course is designed for 16 hours of presentation.

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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 process development where the goal is to understand the root cause of performance problems and implement appropriate CAPA procedures to assure the problem never occurs again.
There are no prerequisites for this course.
Course Objectives
  1. Identify a problem that requires action
  2. Define a problem in measurable terms
  3. Contain the problem while developing a durable solution
  4. Measure core performance and establish metrics
  5. Collect and analyze data relevant to the problem of interest
  6. Analyze the system of causes and determine root cause
  7. Plan and implement corrective and preventative relevant to the root cause of the problem
  8. Evaluate the effectiveness of the solutions
  9. Establish controls to sustain solutions
  10. Use Excel or JMP for basic statistics and data analysis
Detailed Course Outline
Section I: Introduction to root cause analysis
Need for improvement Savings associated with root cause analysis Eight+ basic quality tools
Section II: Define and contain the problem
Define the problem Contain the problem Determine scope, objectives and goals Project leadership and planning
Section III: Measure the problem
Map the process Determine data collection plan Establish metrics and capability
Section IV: Analyze data and determine root cause
Analyze and summarize the data Analyze and summarize the process map Determine root causes and summarize all findings
Section V: Improve performance
Brainstorming solutions and CAPA Benefit, cost, risk and complexity determination Measuring solution effectiveness
Section VI: Control and standardize improvements
Process owner Select controls