FDA Guidance Regarding Software Validation for Clinical Trial Management Systems - Webinar By GlobalCompliancePanel 2012

Topics

• The FDA guidance for industry "Computerized systems used in Clinical Investigations" will be discussed in detail
• Key `software validation` approaches related to CTMS will be presented
• Key CTMS software validation steps will be discussed
• Details appplicable to CTMS development will be detailed as described in the FDA guidance "General Principles of Software Validation"

Who should Attend

• CTMS developers, testers auditors
• Presidents and CEOs of CTMS providers
• Directors of Clinical and Regulatory Affairs
• Site Managers responsible for CTMS selection
• Clinical Research Coordinators & Associates
• Managers of Quality Affairs
• Clinical Project Managers, Research Nurses, Scientists and Others