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Quality Management for FDA-Regulated Pharmaceutical Company

Program Manager Provides Quality Management System Expertise to FDA-Regulated Pharmaceutical Company in Greater Boston Area

Client Profile:

FDA-regulated pharmaceutical environment

 

Business Challenge:

International company with several simultaneous system implementations was facing a serious lack of focus in their quality management system projects and department. Full-time managers were already being pulled into too many directions and the company lacked strong internal Program Management policies within the quality department, which was being most impacted by the new system implementations.

Due to the regulated environment and nature of the company’s business, there were also challenges around validating end products – a big part of the project initiative and the reason behind most of the new system implementations.

 

Project Overview:

  • New quality management system implementation with several associated projects
  • Corrective and Preventive Actions (CAPA) and qualified event module implementation
  • Training management and documentation management
  • Tying project plans and deliverables directly to company processes

 

Delivered Results:

The consultant was able to walk in day one and provide value through peer program management and by monitoring and reporting on project deliverables, which was not being done previously.

The consultant’s extensive experience running programs and implementing new systems – specifically quality management systems – allowed the internal manager to get back to his core responsibilities without compromising the deliverables of the project.

In addition to peer program management and holding internal managers accountable to project deliverables, the consultant also provided project guidance to the department in the form of documented guidelines, project plans and timelines. Recently having come off of a similar project in the same industry, the consultant acted as a true consultant to the company – providing scope and guidance in cross-functional areas impacted by the project.