{"product_id":"fda-s-bioresearch-monitoring-bimo-program-inspection-of-sponsors-cros-and-monitors-2026-05-20","title":"FDA's Bioresearch Monitoring (BIMO) Program: Inspection of Sponsors, CROs, and Monitors","description":"\u003cp\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThis web seminar includes a detailed review of the FDA's Compliance Program Guidance Manual (CPGM) on how agency investigators are trained to conduct inspections of sponsors, Contract Research Organizations (CROs), and monitors involved in the conduct of clinical research. The course will look at the FDA's current focus during inspections and the factors driving these changes. Assessment and discussion of the standard operating procedures that are expected for sponsors and CROs, including registration of trials and informed consent document issues, will be highlighted.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eVideo Preview\u003c\/p\u003e\u003cobject width=\"400\" height=\"225\" data=\"https:\/\/www.youtube.com\/embed\/b6zMz91epDg\"\u003e\u003c\/object\u003e\u003cp\u003e \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eReview how new regulatory requirements are being incorporated into inspections\u003c\/li\u003e \u003cli\u003eDiscuss the CPGM and rules that support changes in inspection focus\u003c\/li\u003e \u003cli\u003eAssess the FDA's application of the inspection manual contents 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 \u003cli\u003eSponsor-Investigators\u003c\/li\u003e \u003cli\u003eSponsor and CRO Representatives\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=\"\/pages\/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 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\u003cb\u003e\u003c\/b\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":52823804084589,"sku":"BI17210","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/fda-s-bioresearch-monitoring-bimo-program-inspection-of-sponsors-cros-and-monitors-2026-05-20","provider":"Barnett International ","version":"1.0","type":"link"}