• Understand your data & system constraints in CMOs management
• Begin the transformation from a tactical and isolated approach to data & system management, to a cross functional and coherent approach to data management
• Identify the realities of a data and system landscape for your company: putting in place a road map to achieving integrated data & system landscape
• Employ tools to create risk assessment/management action plans
• Ensure operational risk management with CGMPs (Current Good Manufacturing Practice) regulations enforced by the FDA
• Engage CMOs in risk management activities
• Discuss Project Risk Management, Risk Management Planning, Monitoring and Controlling risk and Graphical and Quantitative Methods of Risk Monitoring and Reporting