FDA Inspections - Do`s and Don`ts 2019

Topics

• Details surrounding the management of inspections from announcement to close out meeting
• The steps necessary to prepare for an FDA inspection
• The methodology for responding to 483 and warning letters
• Responses to FAQs regarding typical inspector requests during inspections
• The steps necessary to prepare for an FDA inspection
• Common pitfalls to avoid during an inspection
• Responses to FAQs regarding typical inspector requests during inspections
• Details surrounding the management of inspections from announcement to close out meeting
• Common pitfalls to avoid during an inspection
• The methodology for responding to 483 and warning letters
• The steps necessary to prepare for an FDA inspection

Who should Attend

• Regulators
• Internal Auditors
• Compliance Officers
• Legal Departments
• QC Managers
• Validation Managers
• QA Managers