PROBLEM STATEMENT
Client: A large renowned compliance consulting company needed a principal consultant to develop a multi-site holistic remediation plan for warning letters (WL) remediation.
EXPERTISE AND SOLUTIONS
The client company hired a principal consultant from PJI Biotech to develop a multi-site remediation plan. A team of 4 principal consultants worked on the development of a remediation plan for six systems for 7 different sites. The client provided the team with all the documents related to compliance history, internal audit reports, external third-party audit reports, procedures, metrics, and other supporting documents. All the documents were reviewed and analyzed for each site and an overall gap assessment report was generated for each site. Risk ranking was conducted for compliance risks, high-risk areas were identified, and a final remediation plan was developed. Similarly, a separate risk ranking was conducted for product quality and patient safety risks, and a final remediation plan was generated. In addition, heat maps were generated for visual presentation and executive briefings.
RESULTS
As a result, the client was able to complete the development of remediation plans, needed for WL remediations of 7 sites.
FEEDBACK
The client firm was pleased with the final reports, risk ranking, remediation plans, and presentation. As a result, we were asked to support several additional remediation verification projects.