Best Practices for Managing an FDA Inspection
Although an effective Quality System should always be inspection-ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you prepare for and manage inspections efficiently and effectively. A professional, polished, responsive approach sets a good tone for an inspection. You will learn how to present information about your quality system in the most competent and professional manner. Learning ObjectivesFDA Inspection approachInspection preparedness strategy and planningInspection readiness checklistsHow to manage an inspectionKey roles during an inspectionSME (Subject Matter Expert) trainingCommon mistakes to avoidHow to respond to inspection observationsWho Should Attend Quality EngineersCompliance SpecialistsCompliance Managers and DirectorsCAPA specialists and managersComplaint Handling Unit specialists and managersQuality Managers and DirectorsManagement RepresentativesBusiness Leaders wishing to present a professional and compliant organizationCross-functional leaders wanting to make sure their organizations are well preparedAnyone involved with an FDA or NB inspectionWhy Should You AttendAn FDA inspection can be a very stressful and challenging experience. These stresses can lead even experienced people to make very costly mistakes during an inspection. But a good preparation can ease the stresses and lead to much more favorable results. This webinar can help you prepare a strategy and detailed plans to more successfully prepare for, manage, and respond to an FDA or Notified Body Inspection. If you’ve had a recall, an increase in MDRs, or it’s been more than 2 years since your last inspection, you can benefit from this webinar.
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Although an effective Quality System should always be inspection-ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you prepare for and manage inspections efficiently and effectively. A professional, polished, responsive approach sets a good tone for an inspection. You will learn how to present information about your quality system in the most competent and professional manner.
Learning Objectives
- FDA Inspection approach
- Inspection preparedness strategy and planning
- Inspection readiness checklists
- How to manage an inspection
- Key roles during an inspection
- SME (Subject Matter Expert) training
- Common mistakes to avoid
- How to respond to inspection observations
Who Should Attend
- Quality Engineers
- Compliance Specialists
- Compliance Managers and Directors
- CAPA specialists and managers
- Complaint Handling Unit specialists and managers
- Quality Managers and Directors
- Management Representatives
- Business Leaders wishing to present a professional and compliant organization
- Cross-functional leaders wanting to make sure their organizations are well prepared
- Anyone involved with an FDA or NB inspection
Why Should You Attend
An FDA inspection can be a very stressful and challenging experience. These stresses can lead even experienced people to make very costly mistakes during an inspection. But a good preparation can ease the stresses and lead to much more favorable results. This webinar can help you prepare a strategy and detailed plans to more successfully prepare for, manage, and respond to an FDA or Notified Body Inspection. If you’ve had a recall, an increase in MDRs, or it’s been more than 2 years since your last inspection, you can benefit from this webinar.
