Risk management is the bedrock of FDA regulation in the 21st century. Device makers already scramble to keep up with international risk standards; now new legislation on Capitol Hill may require all drug makers to prepare quality risk management plans and conduct periodic audits of their suppliers.

Companies who ignore the heightened public and legal demand for cradle-to-grave product risk management imperil their shareholders and their public reputation.

Enroll your team in the Introduction to Risk Management for FDA Compliance course to train your key staff on one of the biggest compliance pitfalls facing companies today.

You’ll learn: • FDA’s expectations for managing people, product and process risks • The language of risk – concepts and definitions of risk management as used by the FDA • How to better integrate risk management with your quality system • Regulatory foundations for risk management • The role risk management plays in developing compliant GxP and electronic record-keeping systems • Introduction to proven tools different methodologies used for risk assessment • Relationship between “use” and “risk” • How to select the right risk management approach for your organization