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Training Courses - Web Seminar Archives

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Archive: Building Quality by Design (QbD) and Risk-Based Quality Management (RBQM) Systems into Clinical Operations

Course #: BI14041
September 14, 2020

Course Description

The premise behind RBQM is that monitoring quality can be improved by leveraging existing data. The development of quality and risk management metrics involves identifying the values of an organization, and this web seminar will focus on developing measures to assess meeting those goals, building infrastructure to capture data to support the metrics, and establishing adequate and timely responses to drive improvement. As the industry’s utilization of risk-based monitoring continues to increase along with the development and expansion of RBQM, the need for integrating these two concepts is necessary.

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Learning Objectives

  • Describe the principles of QbD and new regulatory requirements for risk-based monitoring
  • Develop relevant metrics as quality and performance indicators for RBQM systems
  • Identify and manage risks of clinical trials
  • Perform cause-effect analysis for identified risks and develop mitigation strategies
  • Review recent noncompliance trends and regulatory focus for Sites, Sponsors, and IRBs
  • Develop effective Corrective and Preventive Action (CAPA) Plans

Who Should Attend

  • Clinical Quality Assurance Auditors
  • Clinical Quality and Compliance Professionals
  • Clinical Research Associates
  • Project Managers and Medical Monitors
  • Regulatory Affairs Professionals
  • Clinical Principal Investigators and Research Coordinators
  • IRB Administrators and Members


Marina Malikova, Ph.D., MSci, M.A., C.C.R.A., RAC

Click here for complete trainer biographies


Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.