Pharmacovigilance / GCP Audit Report Writing
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.