This webinar took place on October 8, 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 will review guidance and considerations for QTL implementation in Clinical Development. Additionally, it will review 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 attendees will come away with:
- 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
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