{"product_id":"navigating-fda-s-june-2024-bimo-inspection-guidance-a-practical-approach-2026-08-07","title":"Navigating FDA's June 2024 BIMO Inspection Guidance: A Practical Approach","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThis web seminar provides a comprehensive overview of the FDA's June 2024 draft guidance on Processes and Practices Applicable to Bioresearch Monitoring (BIMO) Inspections. Participants will gain insights into the key elements of BIMO inspections, including types of inspections, communication best practices, and post-inspection procedures. The course will equip attendees with strategies for preparing for and managing FDA inspections effectively. \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eIdentify types of BIMO inspections and their purposes in FDA-regulated research\u003c\/li\u003e \u003cli\u003eExplain the role of Remote Regulatory Assessments in BIMO oversight\u003c\/li\u003e \u003cli\u003eDiscuss expectations for communication before, during, and after an inspection\u003c\/li\u003e \u003cli\u003eExamine BIMO processes and practices and publicly available resources\u003c\/li\u003e \u003cli\u003eReview relevant sections of the FDA's Investigations Operations Manual (2024)\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eClinical Trial Managers\u003c\/li\u003e \u003cli\u003eRegulatory Affairs Specialists\u003c\/li\u003e \u003cli\u003eQuality Assurance Managers\u003c\/li\u003e \u003cli\u003eClinical Research Coordinators\u003c\/li\u003e \u003cli\u003ePrincipal Investigators\u003c\/li\u003e \u003cli\u003eCompliance Officers\u003c\/li\u003e \u003cli\u003eClinical Operations Directors\u003c\/li\u003e \u003cli\u003eCRO Project Managers\u003c\/li\u003e \u003cli\u003eInstitutional Review Board (IRB) Administrators\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$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 1.5 hours (0.15 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#: 0778-0000-25-023-L99-P. Released: 2\/25. \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":53375390613869,"sku":"BI17355","price":835.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/navigating-fda-s-june-2024-bimo-inspection-guidance-a-practical-approach-2026-08-07","provider":"Barnett International ","version":"1.0","type":"link"}