This course is specifically designed to meet the analytical needs of those individuals working within FDA regulated industries. Areas of instruction cover the topics associated with risk management including risk management definitions, risk management process and risk assessment tools including Failure Modes and Effects Analysis. The course requires 16 hours of instruction.
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.
There are no prerequisites for this course.
Risk management principles
Risk management process
Basic quality tools and risk weighted analysis
Cause and effect diagrams
Process flow and risk assessment
Pareto and Risk Weighted Pareto analysis
Histograms, capability, simulation and Margin
DOE (product and process) and MSA
Application areas for FMEA
FMEA generation workshop
FMEA action plans and risk reduction