Program Management to Improve Best Practices for Global Growth

Problem

US Medical device manufacturer faced with US Food and Drug Administration (FDA) and Department of Justice (DOJ) investigation regarding quality and method of product imported for sale and production of devices in the domestic market.

Solution

As on-site Program Manager, assisted in development of scope of work (SOW) that aligned client and consultant approach to global process and program improvement initiatives to remedy issues with FDA and DOJ in addition to addressing client's move from older manufacturing facility to a new one. The project also focused on improving :

• Supplier and Materials Control
• Design Controls
• Documentation Controls
• Production and Process Controls (P&PC)
• Corrective and Preventive Action (CAPA)

Departments utilized different software programs to manage work, for example, purchase orders, process and procedure documentation regarding supplier assessments were not consistent. The need to correct this would greatly enhance the client's ability for vetting qualified vendors, cut costs, and reduce redundant work. Additionally, the project needed to address improving overall operational efficiency and compliancy measures to ensure :

1. Resolve investigation with FDA and DOJ and developing an environment better suited for product development by adhering to FDA Quality System and current Good Manufacturing Practices (cGMP)
2. Move forward in an environment focusing on best practices with cost-cutting benefits
3. Be scalable as the company expanded operations and have a system to support global manufacturing, distribution, and revenue growth that also aligned with international competent authorities.

By working with subject matter experts combined with client personnel assembled teams and client senior management, created individual team deliverables in Microsoft Project that encompassed a seven stage process from project kick-off to monitoring and evaluation. This included identifying low-medium-high risks (Warning Letter issues being the latter) within the company. From there, created team presentations including approach to remediate top five risks so teams could present to senior management, Steering Committee, and Board of Directors. Throughout engagement responsible for creating tools and metrics reports in Microsoft Excel, Project, and PowerPoint for teams and senior management in addition to controlling costs of project and maintaining timely delivery of team deliverables. Utilized Agile to retrieve process documents and SOPs for team review and revisions to synchronize with SOW and responsible for close-out activities and delivery of final work product to client.

Result

Client has settled with FDA and DOJ and completed and implemented phases of global best practices has met many of the desired project goals. Since project kick-off in 2009, the year to date stock price (on date of this case study), share price has increased by over 200% thus increasing shareholder value in an environment of enhanced compliance and operating efficiency better prepared for global growth.

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