Global Coordination of 23 Facility Upgrades Lifts FDA Warning Letter


A top four pharmaceutical company had a Federal Drug Agency (FDA) warning letter issued to one of its overseas Active Pharmaceutical Ingredient (API) manufacturing sites that had the potential of shutting down one of the company’s major revenue sources. To comply with the commitments made to the FDA and to get the warning letter lifted, the overseas site was required to complete a portfolio of 23 facility upgrade, process, and information technology improvement projects without impacting the API delivery pipeline. This effort required a high degree of coordination between U.S. based corporate middle managers and the overseas plant management.


Integrated Project Management Co., Inc. (IPM) was requested to assist the overseas API manufacturing site management team in defining the projects that comprised the Compliance Program, prioritizing the projects within the portfolio, providing project management assistance to the project leaders, and establishing a critical chain planning methodology within the local culture. Additionally, IPM was responsible for effective communication between the middle management in the U.S. and the overseas API manufacturing site management. The program management required a high level of collaborative effort to ensure a unified approach in defining the program scope and ultimately assisting the plant in implementing the various elements of the program.

The approach to improve the current FDA compliance program performance, mitigate future program risks, and to effectively lead the numerous organizations and teams involved in this program required that disciplined project management and leadership be applied consistently to the overall program. This PMO based approach contributed to achieving the following accomplishments that promoted overall success:

  • Confirmed a universal and consistent understanding of the program objective and deliverables (requirements).
  • Confirmed the alignment of team activities and deliverables with key program deliverables.
  • Assessed performance of the resource structure, schedule and budget control mechanisms, and communication network against the program objective and requirements.
  • Established the optimal team structure and communication network.
  • Developed a detailed Program Plan and Schedule.
  • Identified and communicated program team critical chain dependencies and team responsibilities.
  • Maintained focus on the effective utilization of resources.
  • Facilitated team progress and schedule attainment through issue resolution.
  • Monitored program progress and introduced corrective measures as required to ensure conformance to scope, schedule, and budget.
  • Continually promoted teamwork, communication, and focus to project objectives.


The appropriate planning of all required shutdown activities were completed, resulting in the completion of all associated compliance projects within schedule, cost, and quality requirements. Based on these accomplishments, the FDA warning letter was lifted.