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.
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.
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