Pharmacovigilance Auditing Project
Challenge
Our client received a black box warning requiring a risk evaluation and mitigation strategy (REMS). After implementing the REMS, they submitted several supplemental approvals. They enlisted Beacon Hill Life Sciences to assist with inspection readiness and conduct a mock audit to prepare for an inevitable inspection.
Solution
A senior Beacon Hill Life Sciences pharmacovigilance (PV) auditor reviewed the REMS and the PV department’s current state of compliance. The auditor conducted a multi-department mock inspection and wrote a detailed findings report shortly after completion. She presented the report findings to thirty-five individuals across multiple departments and provided inspection readiness training based upon those findings.
Our client's quality team shadowed the auditor throughout the process to increase their knowledge and experience around inspection readiness, mitigating the risk of future non-compliance.
Achievements
The client went into their inspection aware of their shortcomings and with a plan in place to execute corrective and prevention actions (CAPAs). The inspection results were in line with Beacon Hill Life Sciences’ findings, and the client’s internal quality team was further prepared for future inspections.
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