Training Course Syllabus:
Auditing Clinical Trials for GCP Compliance Webinar
Time: 10:00 AM PST | 01:00 PM EST
Duration: 90 Minutes
Instructor: Calin Popa
Audits from either regulatory bodies and/or the sponsor companies are usual during the development of a clinical trial. The results of an audit affect both, the site and the sponsor of the clinical study. Good preparation for an audit starts from the beginning of the trial by identifying the risks of noncompliance.
Why Should you Attend:
With the growth of the Pharmaceutical and Biotechnology industry, audits are getting more and more frequent. The complexity of the investigational products and of the clinical trial protocols amplified the risks for noncompliance. Noncompliance in clinical trials and misreporting of clinical trial results that took place in the last years made the regulatory bodies to multiply the number of audits. On the other hand, the sponsors also multiplied the audits from their part to downsize the risk of noncompliance during the trial.
This presentation will help you to understand, correct and prevent audit findings.
Objectives of the Presentation:
The objectives of the presentation are to talk about:
- ICH guidelines and Good Clinical Practice (GCP)
- Differences between protocol deviations/violations/exceptions
- Understanding compliance
- Most frequent audit findings
- Audit preparation
- Responding to audit findings