{"product_id":"risk-based-auditing-effective-compliance-strategies-2026-12-18","title":"Risk-Based Auditing: Effective Compliance Strategies","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eAn audit is defined as a systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, the sponsor's standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). Auditing focuses on the systems that generate this data, whereas monitoring tends to focus primarily on the data. Risk-based approaches to auditing, such as focusing on the most critical data elements, are more likely to ensure subject protection and overall study quality, and will permit sponsors to focus their compliance efforts more effectively. This web seminar will provide an overview of risk-based auditing skills and techniques, and a review of recent GCP audit findings from Clinical Investigators (sites), sponsors, and Institutional Review Boards (IRBs).\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eReview similarities and differences in risk-based auditing and monitoring\u003c\/li\u003e \u003cli\u003eExamine the structure of the quality assurance\/quality control relationship\u003c\/li\u003e \u003cli\u003eApply risk assessment and management principles to clinical quality assurance\u003c\/li\u003e \u003cli\u003eReview elements of risk-based auditing and compare to traditional auditing practices\u003c\/li\u003e \u003cli\u003eDiscuss how the timing of the audit impacts risk assessment and control\u003c\/li\u003e \u003cli\u003eEvaluate recent noncompliance trends and regulatory focus for sites, sponsors\/CROs\/monitors, and IRBs\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eClinical Quality Assurance Auditors\u003c\/li\u003e \u003cli\u003eClinical Quality and Compliance Professionals\u003c\/li\u003e \u003cli\u003eClinical Research Associates\u003c\/li\u003e \u003cli\u003eProject Managers\u003c\/li\u003e \u003cli\u003eSponsor Investigators\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 href=\"https:\/\/stage.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#: 0778-0000-23-066-L99-P. Released: 9\/23. \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 \u003cfont color=\"black\" face=\"Verdana, Arial, Helvetica, sans-serif\" size=\"-1\"\u003e \u003c\/font\u003e \u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375365906797,"sku":"BI17601","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/risk-based-auditing-effective-compliance-strategies-2026-12-18","provider":"Barnett International ","version":"1.0","type":"link"}