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How to Prepare for Pharmacovigilance Audits and Inspections

This course will teach you how to prepare for an audit/inspection from the time of the receipt of the announcement to the conclusion.


Every pharmacovigilance function will, at one time or another, undergo governmental or health authority inspections as well as audits by license partners, internal auditors and others. The course will teach you how to prepare for an audit/inspection from the time of the receipt of the announcement (or of the arrival of the inspectors at your doorstep) to the conclusion of the audit or inspection.

What participants from previous courses say:

"The instructor was very communicative, engaged the audience to share experience and was answering any question or finding any solution"
"All sessions were interesting and the information provided was really beneficial and useful. Also the interactive sessions, experience sharing and answers to targeted questions were very useful. Most comprehensive I find the preparation for audits part"

Who should attend?

Professionals who work in:

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

Course level: Intermediate, for professionals who have fundamental understanding of Pharmacovigilance, but not necessarily experience in audits.

Learning objectives

At the conclusion of this course, participants will be able to:

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

Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.

Plan Your Team's Professional Development

Why not take advantage and train your whole department (or even across different departments!) and benefit from increased:

  • Focus
  • Flexibility
  • Convenience
  • Cost Effectiveness

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