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Quality Tolerance Limits as Required by ICH E6(R2): Definitions and Requirements for “Fit-For-Purpose” Compliance, New Webinar Hosted by Xtalks

TORONTO, December 13, 2018 ( – Expectations for quality tolerance limits when conducting Good Clinical Practice (GCP) clinical trials in accordance with ICH E6(R2) have generated a buzz in the industry. Quality tolerance limits 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?

Join industry expert Jay A. Turpen and Steven B. Whittaker, both Senior Consultants at The Avoca Group, for a live webinar on Wednesday, January 9, 2019 at 11am EST (4pm GMT).

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 quality tolerance limits, 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 quality tolerance limits. 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 will include:

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


For more information or to register for this event, visit Quality Tolerance Limits as Required by ICH E6(R2): Definitions and Requirements for “Fit-For-Purpose” Compliance.



The Avoca Group is a life sciences consulting firm dedicated to improving quality and compliance in the clinical trial execution process. Integrating deep subject matter expertise with industry-leading approaches and technology, the company tailors solutions that help companies build quality management, inspection readiness, and effective oversight systems into existing processes. The company operates the Avoca Quality Consortium® (AQC), a collaborative comprised of nearly 100 pharma, biotech, CRO, and clinical service provider companies with the shared objective of elevating clinical trial quality and bringing key stakeholders in the clinical trials process into greater alignment. The Avoca Group’s mission is to have a positive impact on all clinical trials by helping clinical research companies increase quality, ensure compliance, and improve efficiency so that medicines can reach patients faster.



Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.


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Sarah Hand

Tel: +1 (416) 977-6555 ext 224