Risk Management 1: Key Concepts and Definitions

FDA manages risk in an attempt to prevent loss or injury by ensuring their medical devices, human and veterinary drugs, food additives, biologics, or other products are safe. This course focuses on Risk Management as it applies to FDA and its regulated industries. This course is also designed to provide an understanding of Risk Management as defined by the International Organization for Standardization (ISO). Topics in this course include: Risk, Calculating Risk, Safety, and Managing Risk. After completing this course, learners will be able to recognize the key concepts and definitions associated with risk management.

After this course learners will be able to recognize the definitions of risk and related terms. identify the ways risk can be expressed. differentiate between safety and risk. identify the criteria fda uses to judges safety for different types of products. recognize the steps of the risk management process.