{"product_id":"quality-systems-a-controlled-approach-to-gcp-compliance-2026-10-05","title":"Quality Systems: A Controlled Approach to GCP Compliance","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eA Quality Systems approach to establishing and maintaining regulatory compliance allows sponsors to better leverage their resources and Clinical Investigators to meet their obligations for clinical research oversight. This web seminar will review the elements of a Quality System at the Clinical Investigator site and how it functions to proactively control site-level noncompliance. \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDiscuss an overview of sponsor and Clinical Investigator responsibilities\u003c\/li\u003e \u003cli\u003eExplain how to identify the active elements of a functional Quality System at the clinical research site\u003c\/li\u003e \u003cli\u003eDiscuss how implementation of a Quality System can assist in the requirements for meeting obligations of sponsors and Clinical Investigators\u003c\/li\u003e \u003cli\u003eDetermine how Quality System overlaps with FDA and ICH Guidance\u003c\/li\u003e \u003cli\u003eExamine recent compliance concerns and how applying the Quality System framework at the site level can address them\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDirectors of Clinical Operations at clinical research sites\u003c\/li\u003e \u003cli\u003eClinical Principal Investigators\u003c\/li\u003e \u003cli\u003eClinical Research Coordinators\u003c\/li\u003e \u003cli\u003eClinical Research Associates\u003c\/li\u003e \u003cli\u003eProject Managers\u003c\/li\u003e \u003cli\u003eAll Clinical Research Personnel involved in selecting and\/or overseeing clinical research sites\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eElizabeth Ronk Nelson, M.P.H.\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$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#: 0778-0000-24-026-L99-P. Released: 1\/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":53375371379053,"sku":"BI17464","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/quality-systems-a-controlled-approach-to-gcp-compliance-2026-10-05","provider":"Barnett International ","version":"1.0","type":"link"}