Program Management in Post-FDA Warning Letter and Consent Decree Environment

Problem

Fortune 100 medical device manufacturer enters into consent decree with US Food and Drug Administration (FDA) due to infractions in current Good Manufacturing Practices (cGMP) within a group of its products. It is required to review and remediate cGMP gaps and adhere to FDA Quality System regulations in a variety of areas that include :

• Process of recalls
• Design Controls
• Manufacturing
• Production and Process Controls (P&PC)
• Labeling
• Distribution and holding
• Corrective and Preventive Action (CAPA)
• Facilities and Equipment (F&E)

Solution

Served as on-site co-Project Manager to work with consultants and client staff in teams dedicated to addressing each identified cGMP inconsistency within consent decree. Using Microsoft Project to outline gaps and timeline for remediation, helped managed teams with deliverables, timeline, and training material preparation and implementation. Use of Microsoft Excel was more widely on a daily basis given the pervasive availability of the program among client employees that relayed similar information as listed in the overall project plan, reports and metrics were often generated from this tool created in Excel for teams and routine client meetings showing team status and which were ahead or lagging, thus providing the ability to shift resources as needed. The use of SAP was widely used in order to retrieve SOPs and other documents that were required to be addressed and modified.

During the project, assistance was also provided to prepare for a mock FDA inspection by a 3rd-party that assessed progress and identified potential 483 and Warning Letters issues still outstanding as well as those areas that were determined remediated. Assisted in close-out of project by creating an e-Room for the client to store final work documents, history of work performed, and, for some teams, also created hardcopy documentation for client archives that could all be referenced during FDA re-inspection and follow-on monitoring and evaluation phases of project.

Result

Company passed FDA re-inspection and company created spin-off company, increasing market share and shareholder value within a compliant environment.

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