Quality Tolerance Limits Video

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
By |2017-05-10T20:04:09+00:00April 19, 2017|Blog, Webinar|1 Comment

About the Author:

Professional in the integration of data-driven Risk-based Monitoring (RbM) process in international clinical trials of pharmacology. Speaker at regional and global conferences such as: DIA, PharmaForum, PharmaDay, DGGF, etc. 10+ years of experience in data quality projects and biostatistics for the pharmaceutical industry. Life passion: improving clinical research with RbM, driving the RbM research to new frontiers for CROs, pharma and biotech companies.

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