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Event Details


Pharmacovigilance / GCP Audit Report Writing

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Course overview

Audits form an important part of the Pharmacovigilance (PV) and Good Clinical Practice (GCP) quality management systems, and the reports generated provide valuable information to assist companies with maintaining compliance.

This course will provide examples of common issues/pitfalls and will enable you to improve your audit report writing skills, and therefore, give you more confidence in creating effective reports via which your audit outputs can be communicated to your stakeholders.

The course will cover the basic principles of how to communicate throughout the conduct of a PV/GCP audit, culminating in the preparation of the final audit report. This will be achieved through presentations, examples based on the experiences from the presenters and a practical workshop.

Key benefits of attending

  • Gain practical advice on how to improve your audit report writing skills and preparing an effective audit report
  • Understand the basic principles of how to communicate throughout the conduct of a PV / GCP audit
  • Discuss common issues / pitfalls and how to ensure your report conveys the key ndings and messages
  • Ensure your stakeholders understand the issues, why they are important and their impact, and on what basis they have been included in the audit report


Leigh White

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