This clinical trial audit training reviews the key elements of quality auditing processes and correlates them to the ICH guidelines and applicable FDA regulations.
Areas Covered in the Seminar:
- Purpose, objectives, and scope of quality auditing of clinical trials for GCP compliance.
- Auditing vs. monitoring vs. quality control
- Routine vs. for cause
- Types of quality audits.
- Clinical sites
- Phase 1 units
- Clinical summary reports
- Audit preparation and methodology.
- Risk-based approach
- Site and sample selection
- Records and document review
- Paper vs. EDC –type studies
- Audit reporting (e.g. deficiency reporting vs. quality assessment).
- FDA inspection findings and areas of common deficiencies.
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in: Pharmaceutical, Biotechnology, Medical Devices, and Research Facilities Conducting Clinical Trials including:
- Managers in clinical development
- Quality assurance managers and auditors
- Investigator's site management
- Clinical Operations and study conduct staff
- Regulatory Compliance associates and managers
For More Information: