{"product_id":"establishing-quality-tolerance-limits-e6-r2-and-e6-r3-2026-10-02","title":"Establishing Quality Tolerance Limits (E6 (R2) and E6 (R3))","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThe 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.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eUnderstand the background of QTLs and their relationship to CTQ factors, as well as their role in clinical trials\u003c\/li\u003e \u003cli\u003eLearn how to develop and establish ranges in line with ICH E6(R3), including identifying critical processes that impact subject protection and data integrity\u003c\/li\u003e \u003cli\u003eUnderstand the methodology for monitoring QTLs, tracking data, and responding when ranges are exceeded, as well as documenting any necessary adjustments\u003c\/li\u003e \u003cli\u003eGain 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)\u003c\/li\u003e \u003cli\u003eIntegrate QTLs into the Quality Management System (QMS) to ensure ongoing compliance and effective risk management\u003c\/li\u003e \u003cli\u003e* Understand the changes in QTLs from ICH E6(R2) to ICH E6(R3) and how to effectively apply the concepts in trial management \u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eManagers\/Directors: Clinical Operations, Quality Management, Compliance\u003c\/li\u003e \u003cli\u003eClinical Quality Assurance Professionals\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eAndy Lawton\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"https:\/\/www.barnettinternational.com\/instructor-biographies\" title=\"Click here for complete trainer biographies\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$735*\u003c\/p\u003e\u003cp\u003e*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.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett 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. \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.\u003c\/span\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375371542893,"sku":"BI17460","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/establishing-quality-tolerance-limits-e6-r2-and-e6-r3-2026-10-02","provider":"Barnett International ","version":"1.0","type":"link"}