{"product_id":"inspection-readiness-understanding-bimo-inspection-requirements-for-sponsors-cros-monitors-and-investigators-2027-01-15","title":"Inspection Readiness: Understanding BIMO Inspection Requirements for Sponsors, CROs, Monitors and Investigators","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThe primary reason the FDA performs inspections is to support its mission to protect the public by ensuring the safety and efficacy of drugs, biologics, and medical devices. In 2006, the FDA announced an initiative to modernize the regulation of clinical trials, including the Compliance Program Guidance Manual (CPGM) Bioresearch Monitoring Program (BIMO). The purpose of the FDA compliance program is to provide instructions to the FDA field investigator and the FDA center personnel in the conduct of FDA inspections. This web seminar will review both the FDA CPGM BIMO for sponsors, CROs, and monitors and the FDA CPGM BIMO for Clinical Investigators and Sponsor-Investigators.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDescribe how the FDA CPGM BIMO is used in FDA inspections \u003c\/li\u003e \u003cli\u003eDefine the types of FDA inspections\u003c\/li\u003e \u003cli\u003eIdentify the most common type of Inspection findings for sponsors, CROs, and Investigators\u003c\/li\u003e \u003cli\u003eExamine how the FDA CPGM BIMO can aid in preparation for an inspection prior, during, and at the completion of a clinical trial\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eClinical Investigators\u003c\/li\u003e \u003cli\u003eClinical Research Coordinators\u003c\/li\u003e \u003cli\u003eClinical Quality Assurance and Compliance Auditors\u003c\/li\u003e \u003cli\u003eClinical Research Associates\u003c\/li\u003e \u003cli\u003eMedical Monitors\u003c\/li\u003e \u003cli\u003eProject Managers\u003c\/li\u003e \u003cli\u003eRegulatory Affairs Professionals\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eShana Zink, B.S., C.C.R.A.\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 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#: 0778-0000-23-016-L99-P. Released: 1\/23. \u003cspan class=\"bold\"\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\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375364596077,"sku":"BI17628","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/inspection-readiness-understanding-bimo-inspection-requirements-for-sponsors-cros-monitors-and-investigators-2027-01-15","provider":"Barnett International ","version":"1.0","type":"link"}