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Audits and Mock Inspections

Recent FDA 483s, warning letters, and other regulatory documents issued to Sponsors, CROs, IRBs, and Clinical Investigators indicate that the most frequently cited areas for noncompliance are also those that are most easily addressed with focused training programs. An audit is defined as a systematic and independent examination of trial-related activities and documents to determine whether all elements of the clinical research infrastructure are functioning in accordance with the tenants of good clinical practice (GCP) and applicable regulatory requirement(s).

Audits allow an opportunity to capitalize on identified strengths and develop process improvement plans for areas of potential weakness in a highly focused manner. However, perhaps the most overlooked purpose of an audit is to provide an opportunity for education and training. Barnett Educational Services is pleased to provide your organization with Mock Audit and Follow-up Training services, customized to address audit findings. Post-audit training allows you to disseminate information in real-time and therefore effect the timely development of corrective action plans.

Deliverables include:

  • Detailed Audit Agenda
  • Detailed audit report incorporating findings, global and regulatory risk assessment, and corrective and preventive action plan recommendations
  • Audit Certificates
  • Tailored finding-specific training delivered at your facility or choice of venue, designed to incorporate the most current information available on the regulations, agencies, and guidance that govern the conduct of clinical research
  • Current information on new developments and emerging trends within the clinical research industry for consideration

Move away from costly, reactive high-level quality control activities and further maximize resources by placing your training focus on areas that are of greatest regulatory risk.

For more information, please contact:

Naila Ganatra
General Manager
Barnett International
a division of Cambridge Healthtech Institute
ph: (215) 413-2471