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TransCelerate Event

Demystifying Quality Tolerance Limits Webinar

This webinar took place on October 13, 2020. You can watch a recording of the webinar on our YouTube Channel and download a PDF of the presentation.

ICH E6 R2 requires Quality Tolerance Limits (QTLs) as part of Clinical Quality Management. This webinar reviewed guidance and considerations for QTL implementation in Clinical Development. Additionally, it reviewed highlights from the TransCelerate Quality Tolerance Limits Framework, including but not limited to a proposed definition of a QTL, process map/steps, and examples of QTL parameters.

The webinar covers: 

  • An understanding of what a QTL is and is not
  • An awareness of tools that can be used to aide QTL implementation
  • Strategies and considerations for advancing implementation of QTLs

This webinar is intended for: 

  • Anyone in Clinical Development
  • R&D/Clinical Quality
  • Clinical Quality Risk Management

Presenters include:

Dagmar Görtz, Director External Engagement & Business Insights – Janssen

Lukasz Bojarski, Head of Centralized Monitoring – AstraZeneca

Ruma Bhagat, Senior Science Leader, Health Equity & Population Science, Product Development Medical Affairs – Roche

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