{"product_id":"etmf-quality-oversight-a-risk-based-approach-2026-09-15","title":"eTMF Quality Oversight: A Risk-Based Approach","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eWhen applied to electronic Trial Master File (eTMF) oversight, risk-based management is the combination of the potential of quality issues occurring and the impact these deficiencies may have on the integrity of the TMF and the overall Good Clinical Practice (GCP) impact on the study. The TMF is comprised of many records and documents, and a quality TMF is defined as a collection of records, which is complete, collected in a timely manner and comprised of quality records. In the past several years, regulatory agencies have been very clear in their expectation that a sponsor presents a quality TMF during an inspection. This web seminar will examine the concept of a risk-based approach to TMF management and oversight, and, its application to TMF oversight. Included are processes for conducting and documenting quality control (QC) activities that will ensure a high quality eTMF. Quality review findings can then drive the need for additional quality review activities, and by applying these concepts, the sponsor ensures TMF inspection readiness. \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDiscuss the application of risk-based assessment to establish a plan for conducting eTMF QC activities\u003c\/li\u003e \u003cli\u003eExplain various QC activities to ensure a high quality eTMF\u003c\/li\u003e \u003cli\u003eIdentify key TMF artifacts with significant risk for quality issues\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eTrial Master File Directors\u003c\/li\u003e \u003cli\u003eTrial Master File Managers\u003c\/li\u003e \u003cli\u003eTrial Master File Coordinators\u003c\/li\u003e \u003cli\u003eClinical Operations Directors\u003c\/li\u003e \u003cli\u003eTrial Managers\u003c\/li\u003e \u003cli\u003eRecords Management Team Members\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003e\u003cb\u003e\u003ci\u003eThe course will be led by one of the following instructors:\u003c\/i\u003e\u003c\/b\u003e \u003c\/p\u003e\u003cp\u003eDonna W. Dorozinsky, R.N., M.S.N., C.C.R.C.\u003c\/p\u003e\u003cp\u003eJim Markley \u003c\/p\u003e\u003cp\u003eLaura Wiggins, M.B.A. \u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca title=\"Click here for complete trainer biographies\" href=\"https:\/\/stage.barnettinternational.com\/instructor-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$835*\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#: 0778-0000-24-049-L99-P. Released: 9\/24. \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":53375372591469,"sku":"BI17430","price":935.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/etmf-quality-oversight-a-risk-based-approach-2026-09-15","provider":"Barnett International ","version":"1.0","type":"link"}