FDA Guidance Regarding Software Validation for Clinical Trial Management Systems is a webinar that covers topics such as:
- 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"
FDA Guidance Regarding Software Validation for Clinical Trial Management Systems brings together:
- 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
