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 Artem Andrianov, Ph.D., MBA|2020-09-23T10:06:16+02:00April 19, 2017|News|1 Comment

About the Author: Artem Andrianov, Ph.D., MBA

Professional in the integration of data-driven Risk-based Quality Management (RBQM) process in international clinical trials of pharmacology. Speaker at regional and global conferences such as: DIA, Health 2.0, DGGF, etc. 18+ years of experience in data quality projects and biostatistics for the pharmaceutical industry. Life passion: improving clinical research with RbM, driving the RBQM research to new frontiers for CROs, pharma and biotech companies.