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 faced with or organising an audit,
An overview of quality management, quality assurance and quality control in clinical research will be presented. The role of audits in this context will be highlighted, as well as the application of current auditing standards, such as ENGAGE and ISO 19011.
The definition and differentiation of study audits and system audits will be clarified. All steps involved in the audit process - planning, conduct, documentation, follow-up and close-out - will be explained. The course addresses the role of clinical research professionals involved in the audit process such as investigators, Clinical Research Associates (CRAs) and data managers. General expectations and specific requirements from GCP auditors as well as qualification requirements for auditors are included.
Course time09h00 - 17h00
Who should attend
This course is designed for clinical research professionals with previous working experience in a GCP environment. People interested in the ins and outs of Audits. Auditing experience is not required.
- Quality and audit concepts
- Current auditing standards
- Different approaches to planning and conducting audits
- Different types of audits
- Reporting audit findings
- Understand the role of audits within quality assurance
- Differentiate the various types of audits
- Be familiar with applicable audit standards
- Know the data requirements specific to GCP audits
- Prepare for sites and system audits
- Evaluate and write audit findings, audit reports and follow-up actions
- Recognize GCP audits as a method of ensuring data quality