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.
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.
Need for improvement
Savings associated with root cause analysis
Eight+ basic quality tools
Define the problem
Contain the problem
Determine scope, objectives and goals
Project leadership and planning
Map the process
Determine data collection plan
Establish metrics and capability
Analyze and summarize the data
Analyze and summarize the process map
Determine root causes and summarize all findings
Brainstorming solutions and CAPA
Benefit, cost, risk and complexity determination
Measuring solution effectiveness