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Product Testing, Evaluation & Post-Market Issues

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Course Details

This course can only be taken as part of the Certificate in Biomedical Regulatory Affairs.

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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
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