mindsON RBQM | Episode 9 – Quality Tolerance Limits (QTLs)

Strengthen your RBQM skillset by diving into risk management best practices, fostering collaboration and efficiency in clinical trial operations!

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Navigate the complexities of Quality Tolerance Limits (QTLs) in clinical trials with Episode 9 of our mindsON RBQM series.

Predefined Quality Tolerance Limits, mentioned in ICH E6(R2) section 5.0, can be challenging to set up due to their impact on the Clinical Study Report. Our expert instructors, Keith Dorricott, MBB, and Johann Proeve, Ph.D., will guide you through the intricacies of QTLs and help you overcome the challenges they present.

The mindsON RBQM Episode 9 has seven individual on-demand lectures that provide an in-depth insights on Quality Tolerance Limits. These lectures delve into several crucial topics, including understanding the relationship between QTLs and KRIs, adjusting QTLs during a study, and determining the significance of a deviation. Collectively, the lectures offer a detailed breakdown of subtopics under QTLs 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 QTLs and KRIs
  • Defining a QTL with thresholds
  • Determining the significance of a deviation
  • Adjusting QTLs during a study
  • Evaluating the benefits of creating QTLs at study, country, and site levels
  • Assessing the reasonable number of QTLs

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?

Necessary but Complicated? Mastering Quality Tolerance Limits in Clinical Trials | Join Episode 9 of the mindsON RBQM series and master the art of setting up and managing Quality Tolerance Limits in clinical trials, further enhancing your RBQM expertise.


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