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Validity : 04th May'26 to 14th May'26
Auditing Clinical Trials for GCP Compliance
- 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
Overview of the webinar
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.
Who should attend?
This webinar will provide valuable assistance to all personnel in:
- Clinical trial sponsors study team
- CROs study team
- Study Managers, Clinical Team Leads, CRAs
- Principal Investigators, Site Managers and Study Coordinators
- Regulatory Compliance Associates and Managers
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.
Faculty - Mr.Calin Popa
Calin Popa, MD, CCRA is the Founder and President of Advanced Clinical Research Service Inc. a Canadian clinical research consulting company that provides training to FDA and Health Canada regulated industries.
He conducted visits for Pre-Study Site Qualification, Initiation, Monitoring and Close-Out for the purpose of compliance review, drug accountability, site management, safety review, training site personnel, and to assure the integrity of clinical data. Conducted visits to train new CRAs (sign-off visits) and performed online training for CRAs and site staff regarding regulatory compliance and Electronic Data Capture. He holds the CCRA certification from and is an active member of the Association of Clinical Research Professionals.