This session is focused on Quality by Design (QbD) and new regulatory requirements for Risk-Based monitoring and building Risk-Based Quality Management (RBQM) systems.
Besides being a new expectation by regulatory agencies under good clinical practices, Quality by Design (QbD) and Risk-Based Quality Management (RBQM) concepts are receiving attention on a world-wide basis. As the industry’s utilization of risk-based monitoring continues to increase along with the development and expansion of the area of RBQM, the need for the integration of these two concepts becomes apparent.
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, CROs and Sponsors level.
Why You Should Attend:
RBQM is the proactive identification and mitigation of risks. By combining these two concepts, the inherent risks identified up front can feed into the design of the risk-based monitoring plan QbD. RBQM requires development of well-defined and relevant metrics, key performance and quality indicators (KP-QI), as well as a solid process for review and follow-up of the identified signals. Both aspects need to be supported by robust information management as well as training and cross-functional communication strategies.
Practical aspects of developing key performance and quality indicators at all stages of clinical trials will be discussed. Building Quality Management Systems for Sites and Sponsors: Cause-Effect Analysis and Corrective Action Preventive Action (CAPA) plans will be also available as a workshop as part of this course providing an interactive exploration of quality management systems and preparing you to build them in both site and sponsor settings to improve clinical trial operations efficiency and accuracy.
- Describe principles of Quality by Design (QbD) and new regulatory requirement for Risk-based monitoring
- Develop relevant metrics as quality and performance indicators for Risk-Based Quality Management (RBQM) systems
- Identify and manage risks of clinical trials
- Perform Cause-Effect Analysis 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
- Clinical Quality Assurance Auditors
- Clinical Quality and Compliance Professionals
- Clinical Research Associates
- Project Managers
- Medical Monitors
- Regulatory Affairs Professionals
- Clinical Research Coordinators
- Clinical Principal Investigators
- IRB Administrators and Members