Pharmacovigilance / GCP Audit Report Writing

This course will provide you with practical advice in preparing an effective audit report, to ensure your readers understand the findings and the key messages you are trying to convey. Examples of common issues and pitfalls will be discussed to enable you to improve your audit writing skills.

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. The audit report is required in GVP Module IV and is a crucial document in communicating compliance risks.

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. The expert speakers will give practical advice and examples based on their experiences and there will also be an interactive workshop session.

Benefits of attending:

  • Gain practical advice on how to improve your audit report writing skills and prepare 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 findings 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

Who should attend

The course is designed for those personnel involved in the conduct and writing of PV/ GCP audits, and those who are responsible for performing QC review of PV/GCP audits. This includes Quality Assurance auditors in PV or GCP, and supporting personnel such as QA management and training. The course would also be useful for personnel conducting compliance assessments in PV/GCP.

Programme

Writing the audit report
  • The importance of clear communication to ensure stakeholders understand the issues, why they are important and their impact, and on what basis they have been included
  • Where to start and setting the scene for the findings
  • Drafting the findings
    - Defining the issue
    - Evidence and ensuring accuracy of information
    - Impact, expectations/standards, recommendations
    - Examples of how best to phrase and what not to write to try to limit potential misinterpretation
  • Grading the findings – hints and tips
  • Drafting the executive summary – ensuring a balance between detail and attention span
  • QC review – how to conduct, what to look for
  • Post-report communications such as Corrective and Preventative Action (CAPA) support, potential impact on Pharmacovigilance System Master File (PSMF)
Audit communications
  • Communications before, during and immediately following the audit
  • Ensuring a clear understanding of the objective(s) for the audit before it starts
  • Initial messages following the on-site closing visit/review
  • Communication of the annual audit programme to key stakeholders
  • The audit plan and document requests
  • The on-site opening, daily communications, closing meetings
  • Escalation of significant concerns, early notification of critical findings
  • Post-audit debrief
Workshop: audit report writing
  • Write audit findings based on scenarios with different PV/GCP issues
  • Rewrite/critique poorly written findings

Book now

We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.