This course will provide a clear understanding of the requirements and guidelines for Risk Management. The
elements of risk range from product design to post-market, and this range of elements will be discussed.
This course
is intended for personnel in Product and Process Development, Quality Assurance, Validation, Marketing, Manufacturing, Process
Engineering, and others as desired.
Emphasis on the following:
Risk Management Principles
Design Risks
Residual Risks
Production and Post-market Risks
Risk Management
Tools
Risk Review
Risk Ranking