Ensuring your Site is Ready for an FDA Inspection 2019

Topics

• Common mistakes
• General Information about Inspections
• Pre-inspection activities
• Planning for an inspection
• Checklists by area
• When the inspection is announced
• After the inspection
• During the inspection
• Guidance for a 483 response

Who should Attend

• Managers in functions outside of Quality wanting to prepare their organizations for an FDA inspection
• Individuals new to Medical Device companies
• Compliance Personnel who will be the key contact during an FDA Inspection
• Individuals that may be called in as subject matter experts during inspections