Building QbD and RBQM Systems into Clinical Operations

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.

Areas Covered in the Session :

  • 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
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
  • Clinical Principal Investigators
  • IRB Administrators and Members


Dr. Malikova has over twenty years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology.

Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She also holds a Master’s Degree in Clinical Investigation and Project Management Certification from Boston University.

In her current role as Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations, quality assurance, risk management, safety monitoring, strategic planning, and macro-management of research programs. She provides guidance and oversight to the Project Managers, Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), and laboratory staff. She advises faculty/staff on protocol and informed consent writing; assists with BU IRB applications and submissions; provides oversight for data user agreements, cost coverage analysis and budgets development, contracts and licensing for clinical research; and ensures compliance.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance