Remote audits

Remote audits

This course will cover remote audits, virtual Inspections, and other alternative tools and methods regulators have implemented, particularly during the Covid 19 pandemic.

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Curriculum0 hr 40 min

  • Introduction 0 hr 1 min
  • Challenges and Lessons from the Covid 19 Pandemic
  • An Overview of Remote Audits and Inspections in the Medical Device Industry 0 hr 2 min
  • Industry Guidance from the FDA
  • The Challenges of Remote Audits and Inspections 0 hr 3 min
  • How Notified Bodies have handled Covid Audits 0 hr 3 min
  • How FDA has handled Covid Inspections 0 hr 2 min
  • What to Expect
  • What if the FDA wants a Remote Inspection?
  • Preparing for a Remote Inspection or Audit 0 hr 3 min
  • Preparation and Rapport 0 hr 3 min
  • What to Expect from a Remote Interactive Evaluation with the FDA 0 hr 5 min
  • What's Next?
  • Have Audit Best Practices Changed? 0 hr 2 min
  • Beyond the Pandemic 0 hr 5 min
  • Summary
  • Knowledge Check 0 hr 10 min
  • Wrapping things up... 0 hr 1 min
  • Audits and Greenlight Guru 0 hr 1 min
  • Conclusion 0 hr 1 min

Curriculum0 hr 40 min

  • Introduction 0 hr 1 min
  • Challenges and Lessons from the Covid 19 Pandemic
  • An Overview of Remote Audits and Inspections in the Medical Device Industry 0 hr 2 min
  • Industry Guidance from the FDA
  • The Challenges of Remote Audits and Inspections 0 hr 3 min
  • How Notified Bodies have handled Covid Audits 0 hr 3 min
  • How FDA has handled Covid Inspections 0 hr 2 min
  • What to Expect
  • What if the FDA wants a Remote Inspection?
  • Preparing for a Remote Inspection or Audit 0 hr 3 min
  • Preparation and Rapport 0 hr 3 min
  • What to Expect from a Remote Interactive Evaluation with the FDA 0 hr 5 min
  • What's Next?
  • Have Audit Best Practices Changed? 0 hr 2 min
  • Beyond the Pandemic 0 hr 5 min
  • Summary
  • Knowledge Check 0 hr 10 min
  • Wrapping things up... 0 hr 1 min
  • Audits and Greenlight Guru 0 hr 1 min
  • Conclusion 0 hr 1 min

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