Course Description

The ICH GCP E6 R3 update builds on the foundation set by E6 R2, particularly with regard to risk management in clinical trials. While E6 R2 introduced the concept of Quality Tolerance Limits (QTLs) to address risk control, the R3 revision enhances the QTL concept at the trial level as well as adding in "Acceptable Ranges”. QTLs are intended to ensure that clinical trials maintain data integrity, subject safety, and reliable results while adapting to the complexities of modern trial designs. This web seminar will explore the methodology for establishing, evaluating, and maintaining appropriate ranges, their relationship to Critical to Quality (CTQ) factors, and their role in Quality by Design (ICH E8 R1), Continuous Quality Improvement (CQI) and the move towards defined quality. Participants will learn how to implement QTLs effectively in the context of clinical trials and decision-making.

Learning Objectives

• Understand the background of QTLs and their relationship to CTQ factors, as well as their role in clinical trials
• Learn how to develop and establish ranges in line with ICH E6 R3, including identifying critical processes that impact subject protection and data integrity
• Understand the methodology for monitoring QTLs, tracking data, and responding when ranges are exceeded, as well as documenting any necessary adjustments
• Gain insights into how to study, report, and act on breaches of established Ranges, including conducting root cause analysis and documenting findings in the Clinical Study Report (CSR)
• Integrate QTLs into the Quality Management System (QMS) to ensure ongoing compliance and effective risk management
• Understand the changes in QTLs from ICH E6 R2 to ICH E6 R3 and how to effectively apply the concepts in trial management

Who Should Attend

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

Instructor

Andy Lawton

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Registration Fees

$735*

*Includes up to 20 participants per login at a single location. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-25-029-L99-P. Released: 2/25. 

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