Pharmaceutical and biotech companies have been facing increasing demands to improve their organizational effectiveness through information sharing and collaboration. At the same time, there is an important need for a controlled document management system that is compliant with FDA regulations. In this conference, our speakers look at the steps necessary to design and implement Microsoft SharePoint within the confines of a regulated environment. The presentation discusses various solutions, with a special focus on regulatory needs at various stages of the drug development lifecyle.

Speakers John Postle and Cary Cyr explain how to achieve ongoing compliance through the use of SharePoint as a validated application in a qualified environment. They also present a real-life case study from Tufts Medical Center, which illustrates how research laboratories are using SharePoint for collaboration.

This audio conference covers:

• Steps to create a compliant document management system
• The importance of access control within a document management system
• Ways to set up SharePoint
• Examples of using SharePoint for digital signatures of documentation
• A case study of how a CRO is using SharePoint for collaboration

About the speakers:

John Postle, Vice President, Life Science Enterprise, joined Court Square Group in 2007. His primary area of focus is related to enterprise applications and services. Prior to joining Court Square Group, John spent over 11 years with Pfizer. As Technology Portfolio Manager, he supported Pfizer Global Research and Development, as well as the finance, procurement, environmental health, legal, human resources and corporate quality groups.

Prior to his tenure with Pfizer, John held several senior positions with a major financial institution and helped establish Deloitte’s Management Consulting practice in southern New England. He holds a BS from Auburn University, an MBA from the University of Connecticut, is a CPA and has received PMP certification from the Project Management Institute.

Cary Cyr is a Senior SharePoint Specialist for Court Square Group. He has been with Court Square for 10 years, and has held such roles as Project Manager and Technical Subject Matter Expert. Prior to joining Court Square, Cary worked for United Technologies as a systems analyst.

Cary has a BA in Computer Systems Engineering from the University of Connecticut, and holds a number of certifications, including those granted by Microsoft and ITIL.

Who should attend?

• IS/IT
• Regulatory Affairs
• Scientists
• Clinical Researchers