How to Prepare for PhV Audits and Inspections

How to Prepare for PhV Audits and Inspections covers topics such as:

  • 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

How to Prepare for PhV Audits and Inspections brings together:

  • 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

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How to Prepare for PhV Audits and Inspections 2020


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