mindsON RBQM | Episode 7 – Linking Risks & Issues

Navigate the future of RBQM, examining emerging trends, technologies, and regulatory changes to stay ahead in the ever-evolving clinical trial landscape!

Consider unlocking the Essentials of RBQM: Invest in the mindsON RBQM Episodes 1-7 Bundle, find more information here…


Elevate your Risk-Based Quality Management knowledge with Episode 7 of our mindsON RBQM series: Linking Risks & Issues.

This workshop focuses on the connections between root cause analysis for significant non-compliances, as mentioned in Section 5.20.1 of ICH E6(R2), and Risk-Based Quality Management outlined in Section 5.0. Our expert instructors, Keith Dorricott, MBB, and Johann Proeve, Ph.D., will share their insights on integrating root cause analysis and RBQM for a holistic approach to linking risks and issues in clinical trials.

The mindsON RBQM Episode 7 has six individual on-demand lectures that provide an in-depth insights into linking risks and issues. These lectures delve into several crucial topics, including understanding the relationship between root cause analysis and RBQM, recognizing the connection between risks, potential issues, and risk controls, and assessing the role of historical data on issues in risk evaluation and control. Collectively, the lectures offer a detailed breakdown of subtopics under linking risks and issues in clinical trials. In order to get the most value from this Episode, we recommend watching previous episodes first.

About mindsON RBQM 

mindsON RBQM is a comprehensive workshop series that focuses on the practical elements of RBQM implementation and everyday execution. It offers an extensive array of resources to give you the tools you need to be successful in this industry. You can easily fit e-learning into your busy calendar thanks to each episode’s numerous brief lectures, none of which last longer than 12 minutes. The format of this series is based on the popular live mindsOn workshop series. The series includes interactive elements, such as polls, thinking, and quiz-type exercises. These elements challenge learners to comprehend the RBQM concept fully. Furthermore, the training courses offer insightful viewpoints and stimulating discussions. By including an engaging problem-solving activities, this series helps learners overcome the challenges and complexities of RBQM in clinical trials.

If you want to learn more about practical implementation of risk based quality management strategies? Be sure to check our other courses here.

  • Understanding the relationship between root cause analysis and RBQM
  • Recognizing the connection between risks, potential issues, and risk controls
  • Assessing the role of historical data on issues in risk evaluation and control
  • Exploring the links between corrective and preventive actions, and risk controls

Who should attend?

  • Clinical Project Managers
  • Clinical Research Associates
  • Data Managers
  • Quality Assurance Professionals
  • Regulatory Affairs Specialists, Medical Monitors
  • Site Managers
  • … and all other Clinical Research Professionals

Why should you attend?

Integrating Root Cause Analysis and Risk-Based Quality Management in Clinical Trials | Don’t miss this opportunity to expand your understanding of the connections between risks, issues, root cause analysis, and Risk-Based Quality Management. Join Episode 7 of the mindsON RBQM series and take another step towards mastering RBQM in clinical trials!


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