Clinical trial audits and inspections are critical components of the clinical trial process, as they help to ensure the quality, safety, and compliance of the trial. The audits and inspections are critical for ensuring that the data generated during the trial is accurate and reliable and that the trial is conducted in accordance with the study protocol and relevant regulations.
This course focuses on the skills required to prepare and host third-party audits and/or regulatory inspections, Students will be exposed to the procedures involved in planning, conducting and reporting inspections/audits, specifically at clinical investigator sites.
Upon completion of this course, students will know how to prepare and host audits as well as how to respond to audit findings. Topics such as root cause analysis (RCA) and corrective and preventative actions (CAPA) are discussed in detail.
Learning Points:
- Audit VS. Inspection
- Audit Plan and Design
- Documentation Review and Analysis
- How to Prepare for Audits and Inspections
- Corrective Action and Preventive Action (CAPA), Follow-up and Closure
- FDA Bioresearch Monitoring Program (BIMO)
- Common Inspection Findings
- CAPA Plan development