FDA Inspections: From SOP to 483

Topics

• Development and contents of an SOP for FDA inspection
• How to prepare for an FDA inspection
• How to behave during an inspection
• Personnel training before inspection
• Response to investigation findings
• Limitations of the scope of an inspection
• FDA guidance documents used by their inspectors

Who should Attend

• Quality Control Departments
• Quality Assurance Departments
• Regulatory Affairs Departments
• Compliance Departments
• CAPA Specialists
• Engineering Departments
• Consultants and Contractors
• Management Representatives
• Who may have direct interaction with FDA officials