How to Prepare for PhV Audits and Inspections 2016

Key Topics

• Prepare responses to audit/inspection findings, including responses and corrective/preventive action (CAPA) plans
• How to handle the actual audit/inspection and responses to requests and findings based on the:
  • The legal basis of inspections or
  • Audit/inspection methodology
  • The contractual basis of audits
• Assess regional differences with respect to European and US FDA inspections
• Prepare their function for an audit/inspection: roadmap, teams, tasks, and documents

Who should Attend

• Regulatory Affairs
• Pharmacovigilance/Drug safety (QPPV)
• Medical Information
• Quality & Compliance
• Compliance
• Risk Management
• Management Staff Responsible for Running Inspections
• Pharmacovigilance Auditors
• Employees (directly and indirectly) Involved in Inspections