The course will cover the history and current context of GCP QA auditing, selection of investigator sites for audit, preparation and conduct of investigator site audits, audit report writing and follow-up, CAPA plans and metrics. One session will be devoted to trouble-shooting and practical aspects, including communication. There will also be several practical exercises.  

You want to know more about auditing and/or the techniques used in GCP-auditing? You do not see the difference between quality assurance and quality control? This course is designed to provide a basic understanding of the Good Clinical Practice (GCP) audit process in clinical drug development and to demonstrate the importance of audits in ensuring good data quality. It will include practical tips when conducting an audit. An overview of quality management, quality assurance and quality control in clinical research will be presented. The role of investigator site audits in this context will be highlighted, as well as the application of current auditing standards, such as ENGAGE and ISO 19011. All steps involved in the audit process - planning, conduct, documentation, follow-up and close-out - will be explained. General expectations and specific requirements from GCP auditors as well as qualification requirements for auditors are included.