Management Responsibility for Quality: What FDA Expects

Under FDA law and regulations, an effective and compliant Quality System literally begins and ends with management. This course explains who is considered management by FDA, what are management’s responsibilities under FDA Good Manufacturing Practices, how FDA inspectors decide if management is meeting its obligations, and what are possible consequences if it is not. Topics in this course include: Authority, Quality System, Management Role, Quality Audits, Training, Outsourcing, and FDA Inspections. After completing the course, learners will be able to recognize how and why a successful Quality System depends on active management support and involvement to ensure safe and effective products reach patients and customers.

After this course learners will be able to identify management’s specific responsibilities in developing and maintaining a quality system.