Text Box: Clinical Manufacturing Facility Bio/Pharma Industry Problem / Situation: The project product was an aseptic vial filling line being developed for clinical trials manufacturing. The project scope involved a complete design and build of new facilities in an existing building where research and clinical manufacturing was ongoing. The new facility required integration of new with existing - new process equipment with existing and a new automation / SCADA system with existing systems. A full range of validations was required from the new equipment through shipping studies. Apogee Management Group was retained to develop an integrated schedule for managing the project scope for the new clinical manufacturing facility. The project had already commenced and target milestones were established. Process equipment was in the procurement stage; documentation had been started; facility construction was well underway; and automation development had commenced. This heightened the urgency to establish the schedule to attain control of the project and assess the critical path activities. The multidisciplinary nature of the project resulted in significant activity interdependencies. Establishing the dependencies and associated realistic task durations required gaining commitments from resources that were already committed to multiple activities and other projects. Solution and Approach: The process utilized was essentially classic project management. Main deliverables were clearly identified and decomposed into subdeliverables. The structure for how the project was to be managed, that is internal procedures used by the client were identified and used to guide further detailing of the schedule down to an activity level. Subsequently, resources and responsibilities were assigned to all activities. Individual meetings were facilitated with the deliverable owners to refine the activities, their interdependencies and establish realistic durations. An iterative approach was used to arrive at a workable network diagram. Results / Outcome: A comprehensive network diagram identifying the critical path was completed within the time frame required by the client. The completed schedule modeled the work flow of the facility installation through validation for production readiness. The format provided a tool by which the project could be monitored and controlled. Apogee Management Group LLC PO Box 1298 Portsmouth, NH 03802 Phone: 603-431-4764 Email: rcimini@ApogeeMG.com

Engineering Project Leadership

Apogee Management Group

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