The premise behind RBQM is that monitoring quality can be improved by leveraging existing data intelligence. This, in turn, calls for more robust quality assurance (QA) systems focused and efficient resource utilization and allocation at the clinical site level. Why should you Attend: Practical aspects of developing relevant Key Performance and Quality Indicators (KP-QIs) for Risk-Based Quality Management will be discussed.
Areas Covered in the Session :
Identify and manage risks of clinical trials
Perform Cause-Effect Anaylysis for identified risks and develop mitigation strategy
Review recent noncompliance trends and regulatory focus for Sites, Sponsors, and IRBs
Develop effective Corrective Action Preventive Action (CAPA) Plans
Who Should Attend:
Clinical Quality Assurance Auditors
Clinical Quality and Compliance Professionals
Clinical Research Associates
Project Managers
Medical Monitors
Regulatory Affairs Professionals
Clinical Research Coordinators