Introduction to Risk Management for FDA Compliance
(4 hour course)
Thursday (8:30 a.m. - 12:30 p.m.)
Course Content:
Regulatory History of Risk Management
Regulatory foundations for risk management
The Language of Risk and its Meaning
Concepts and definitions of risk management as used by the FDA
Relationship between “use” and “risk”
Risk Foci and Management Approaches
FDA’s expectations for managing people, product and process risks
The role risk management plays in developing compliant GxP and electronic record-keeping systems
Risk Management Tools and Methods
Introduction to proven tools for risk assessment
How to better integrate risk management with your quality system
How to Choose the Appropriate Method
Select the right risk management approach for your organization
