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CASE STUDIES IN PHARMACEUTICAL PROJECT MANAGEMENT: A TECHNICAL FORUM

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The project team will determine, in accordance with ABC Corp. organizational policy, the communication methods and technologies based on several factors to include: stakeholder communication requirements, available technologies (internal and external), and organizational policies and standards. ABC Corp. maintains a SharePoint platform within the PMO which all projects use to provide updates, archive various reports, and conduct project communications. This platform enables senior management, as well as stakeholders with compatible technology, to access project data and communications at any point in time. SharePoint also provides the ability for stakeholders and project team members to. | Supplement to the February 2012 Issue of 2012 Pharmaceutical PharmTech.com The Authority on Drug Development Manufacturing D I w PREFERRED PROVIDERS A DVAN STAR PHARMACEUTICAL Finding the Project Management Case Studies in Pharmaceutical Project Management A Technical Forum Moderated by Patricia Van Arnum Effective project management is an invaluable competency in a successful outsourcing relationship. Project management underpins successful relationships between contract technology and service providers and their sponsor companies. As pharmaceutical companies increase their level of outsourcing it becomes increasingly important for contract technology and service providers to provide not only the technical capabilities needed to execute a given project but the management skills to deliver a project on time to specifications and with the necessary communication to prevent or mitigate project delays. To illustrate the importance of project management in outsourcing several industry members provided case studies on how to coordinate organize and implement a successful project. Blow fill seal manufacturing Norman Weichbrodt strategic account manager at Catalent Pharma Solutions Catalent Pharma Solutions is a provider of drug and biologic development services delivery technologies and supply solutions. Effective project management is the cornerstone of being a complete provider of services ranging from development of new products to technical transfer of existing products. Building the proper project team and employing the correct methodology for handling a complex project is the foundation on which success is achieved. In July 2010 Catalent was approached by a major pharmaceutical customer to transfer an ophthalmic product approved for sale in Europe to Catalent s blow fill seal BFS manufacturing site in Woodstock Illinois. The successful technical transfer of the manufacturing process for this product would potentially lead following FDA approval of the product .

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