This GCP compliance in Clinical Trials training aims to provide an overview of the parameters critical in ensuring GCP compliance and in doing this, will translate GCP in a more practical, applied sense.
Areas Covered in the Seminar: - Importance of Good Clinical Practice.
- Key areas of deficiencies in Clinical trials.
- Common findings in audits and inspections.
- Definition of ranking of findings: minor-major-critical.
- Definition of Adverse and Serious adverse events.
- ICH guidelines on the Informed consent process.
- Management of investigational drug.
- Investigator site file and essential documents.
- Source data.
- Site and people management.
Who Will Benefit:This webinar will provide valuable assistance to all personnel in: Pharmaceutical, Biotechnology, CROs and Research Facilities Conducting Clinical Trials including:
- Managers in Clinical Development and Project Leaders
- Quality Assurance Managers and auditors
- Clinical Research Associates
- Clinical Operations Staff
- Regulatory Compliance Associates and Managers
- Investigators, site coordinators and subinvestigators
