About this Course
This course covers the regulatory requirements for post-market requirements, reporting and enforcement actions. Emphasis is placed on inspection (internal and by regulators), preparation, conduct and follow-up actions. Presentation and team skills are also highlighted during the course. As a final class project, you’ll apply the knowledge gained in the course related to regulatory strategy and policies.
What You'll Learn
- Audits and FDA site inspections
- Warning letters, consent decrees and injunctions, civil and criminal penalties
- Post-market surveillance, including adverse event reporting and risk management
- Corrections, removal and recalls and product labeling issues