This course will provide you with practical advice on 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.
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:
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.
We don't have any currently scheduled dates for this course but we can customise it to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training expert Aleksandra Beer to discuss your requirements: