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 not only look at the steps that have been successful for designing, configuring, and implementing Microsoft SharePoint within the confines of a regulated environment, but also review organizational collaboration features (wikis and blogs) and document workflows that organizations are using.

Speakers John Postle and Kent Fernald explain how to achieve ongoing compliance through the use of SharePoint as a validated application in a qualified environment. They also present real-life examples of several regulatory compliant business applications that have been developed using the SharePoint platform.

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 and automated workflows
• A case study of how a CRO is using SharePoint for generating compliant automated reports

About the speaker:

John Postle, Vice President, Life Science, 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.

Kent Fernald is Development Manager and CTO for Court Square Group. He has been with Court Square for four years, and previously served as Director of Technology. Prior to joining Court Square, Kent owned a software company. Kent has a BBA in Finance from the University of Massachusetts and an MBA from Western New England College. He holds a number of certifications, including those granted by Microsoft and ITIL.

Who should attend?

• Regulatory Affairs Directors
• Quality Directors
• IT Directors and Managers
• Clinical Affairs Directors