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Webinar: Quality Tolerance Limits (QTLs) as required by ICH E6 (R2): Definitions and requirements for “fit-for-purpose” compliance

Recorded Wednesday, January 9, 2019  |  11:00am – 12:00pm EST


Expectations for Quality Tolerance Limits (QTLs) when conducting Good Clinical Practice (GCP) clinical trials in accordance with ICH E6 (R2) have generated a buzz in the industry. QTLs have historically been required for Good Manufacturing Practice (GMP) activities, inferring limits by which significant actions must be taken to ensure the manufactured product achieves quality and usability limits. With Regulators now using the same terminology for GCP clinical studies, what is truly expected?

ICH E6 (R2) describes in Section 5.0.4: The Sponsor should decide which risks to reduce and/or which risks to accept. The approach used to reduce risk to an acceptable level should be proportionate to the significance of the risk…Predefined quality tolerance limits should be established, taking into consideration the medical and statistical characteristics of the variables as well as the statistical design of the trial, to identify systematic issues that can impact subject safety or reliability of trial results. Detection of deviations from the predefined quality tolerance limits should trigger an evaluation to determine if action is needed.”

This interactive webinar will clarify terminology, including metrics, performance indicators, and tolerance limits. It will also provide insights about relevant clinical trial parameters that merit QTLs, approaches to establish appropriate limits, and methodology for monitoring and controlling study activities to minimize risk and likelihood to reach tolerance limits that warrant action.

Leading practices within The Avoca Quality Consortium (AQC), with insights from nearly 100 Member companies, provide a wealth of information for setting and managing QTLs. A “fit-for-purpose” fashion takes into account differences between study phase, complexities, and also company size (e.g., large pharma relative to small biotech). Concepts for applying fit-for-purpose perspectives will be shared, including practical approaches for engaging clinical study teams across the boundaries of sponsor, provider, and investigative sites.


Key takeaways:

  • Clarification of definitions surrounding QTLs for GCP clinical trials
  • Types of parameters that warrant QTLs
  • Effective management of risk using performance indicators and QTLs
  • “Fit-for-purpose” concepts for applying QTLs across phases of clinical trials and sponsor type


This webinar is suited for:

  • Clinical Operations Leaders
  • Biostatistics Leaders
  • Clinical Team Leaders
  • Clinical Compliance Officers
  • Clinical Quality Assurance Leaders
  • Data Management Leaders
  • Medical Affairs Leaders




Jay Turpen

Senior Consultant, The Avoca Group


Steve Whittaker

Senior Consultant, The Avoca Group


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