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
  • Databases
  • 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:
http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701745?channel=biofind