{"product_id":"auditing-sponsors-and-cros-deconstruction-and-application-of-the-fda-s-compliance-program-guidance-manual-2026-09-02","title":"Auditing Sponsors and CROs: Deconstruction and Application of the FDA's Compliance Program Guidance Manual","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eAs scrutiny of sponsors, Contract Research Organizations (CROs), and monitors involved in the conduct of clinical research intensifies, companies are using their quality assurance resources to review internal (and vendor) systems to ensure compliance within a changing regulatory environment. A systematic application of the Compliance Program Guidance Manual (CPGM) permits identification of regulatory risks during qualification and in-process audits. This web seminar will review the FDA's current guideline for conducting inspections and how to apply them to assess Quality Systems. Assessment of the SOPs that are expected for sponsors and CROs, including registration of trials and informed consent document issues, will also be discussed.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eIntegrate new regulatory requirements and processes into audits\u003c\/li\u003e \u003cli\u003eTranslate inspection criteria to Quality Systems that support changes in inspection focus\u003c\/li\u003e \u003cli\u003eAssess the FDA's application of the CPGM as reflected in regulatory communication\u003c\/li\u003e \u003cli\u003eExamine steps for preparation of an inspection\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eProfessionals from Academia whose institutions or investigators hold INDs or IDEs, or whose institutions support clinical research with Site Management Organizations (SMOs)\u003c\/li\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\u003eMedical Monitors\u003c\/li\u003e \u003cli\u003eRegulatory Affairs Professionals\u003c\/li\u003e \u003cli\u003eClinical Research Coordinators\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#: 0778-0000-24-042-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":53375388385645,"sku":"BI17394","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/auditing-sponsors-and-cros-deconstruction-and-application-of-the-fda-s-compliance-program-guidance-manual-2026-09-02","provider":"Barnett International ","version":"1.0","type":"link"}