Video from our recent CyntegrityEDU Webinar – ICH E.6(GCP) Addendum Quality Tolerance Limits

Part 1. ICH E6 background (Structural & Non-structural)

  • Quality Tolerance Limits (QTLs)
  • Brief history of QTLs
  • How to use the QTLs
  • Potential benefits

Part 2. Technology consideration of QTLs

  • Considerations of enabling the QTLs
  • Challenges of QTLs
  • End user requirements
  • Data sourcing
  • Application of the Automatic systems
  • Differences in approaches: timeliness, scope
  • Statistical methods
  • Predictive analytics
  • Success measures