Building Quality Management Systems for Sites and Sponsors: Root Cause and CAPA
This training program will help you implement a Quality Management System (QMS) and prevent findings related to patient safety, data quality and regulatory compliance.
With the industry moving away from detecting and fixing problems to preventing them, quality management systems (QMS) play a crucial role. The impact of not implementing or incorrectly using an effective QMS can be substantial and far-reaching, and may include putting human subject integrity and well-being at risk, inaccurate trial data and regulatory non-compliance.
Course topics include:
Development and application of Corrective and Preventive Action (CAPA) plans
Conduct of Root Cause Analysis (RCA)
Development and application of risk management strategies
Upon completion of this training program, participants should be able to:
List four components of a Quality Management System.
Define quality planning, quality control, quality improvement, and quality assurance.
Define Corrective and Preventive Actions (CAPA) and Root Cause Analysis (RCA).
Explain clinical trial quality management system methodology.
List two key factors of a Quality Management System.
This course helps clinical researchers of all types build competency in Clinical Trials Operations (GCPs), Communication and Teamwork, Ethical and Participant Safety Considerations, Leadership and Professionalism, and Study and Site Management. Explore Competencies >