Establishing Quality Tolerance Limits (E6 R2) and Ranges (E6 R3)

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, as well as the role of QTLs in Quality by Design (ICH E8 R1) and Continuous Quality Improvement (CQI). ICH E6 R3 (draft) has seen the replacement of QTLs with Ranges, the relationship between the two will be examined as well as when to use.

Learning Objectives

• Understand the background of QTLs: Purpose and relationship to Critical to Quality (CTQ) factors; role of QTLs in industry
• Developing QTLs: Examine the protocol to identify critical processes that impact subject protection and data integrity; document the process, evaluate requirements, and implement QTLs
• Monitoring QTLs: Track and assess data, respond when QTLs are exceeded, document to justify QTL changes
• Study, report, and act on QTL breaches: Perform root cause analysis, documentation in the Clinical Study Report (CSR); examine how other companies use QTLs
• Integrating QTLs into the Quality Management System (QMS)
• Understand the link between QTLs and Ranges ICH E6 R3 (draft) and what to use
• The link between Ranges in ICH E6 R3 (draft) and QTLs

Who Should Attend

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

Instructor

Andy Lawton

Click here for complete trainer biographies

Registration Fees

$735

Includes up to 20 participants at one site. 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 sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com 

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#: 0778-0000-24-033-L99-P. Released: 2/24. 

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