Checkout 0
Training Courses - Web Seminar Archives

Purchase the recording of a web seminar you have attended in the past and SAVE 50%! Contact Barnett Customer Service for details: +1 781.972.5400 or toll-free in the U.S. at 800.856.2556.

Web Seminar Archives provided through Barnett’s Learning Management System (Single User access) or by electronic file transfer (Site License).

Site license archives are also available in SCORM format for LMS integration. Please contact Barnett at (215) 413-2471 for more details and pricing on SCORM files.

Bulk Archive access is available via Barnett’s Training Subscription. Click here to learn more.

Archive: Establishing Quality Tolerance Limits

Course #: BI14018
August 13, 2020
WebSeminarArchive

Course Description

ICH GCP E6 R2 Section 5.0 has given the clinical research industry the guidance to incorporate and customize all facets of risk management in clinical trials. Section 5.0.4, Risk Control, asks that predefined quality tolerance limits (QTLs) be established considering the medical and statistical variables that can impact subject safety or the reliability of trial results through the identification of systematic issues. Once detected, those issues can be evaluated and acted upon. In this web seminar, participants will learn the methodology for establishing, evaluating, and maintaining appropriate QTLs as they relate to clinical research trials.

Video Preview

 

Learning Objectives

  • Define QTLs and understand their purpose
  • Evaluate the requirements that propel the development of QTLs
  • Examine the protocol to identify critical processes that may impact subject protection and/or data integrity
  • Document the development process
  • Implement established QTLs
  • Track and assess data to establish whether they are within QTLs
  • Respond when the QTLs are exceeded
  • Recognize evolution of QTLs over the life of a clinical trial
  • Modify QTLs depending on circumstances
  • Document to justify any changes to QTLs

Who Should Attend

  • Managers/Directors: Clinical Operations, Quality Management, Compliance
  • Clinical Quality Assurance Professionals

Instructor

Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP

Click here for complete trainer biographies

 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.