{"product_id":"current-fda-and-ema-inspection-findings-lessons-learned-2026-10-01","title":"Current FDA and EMA Inspection Findings: Lessons Learned","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eFailure to follow the investigational plan, inadequate Principal Investigator (PI) oversight, and informed consent irregularities remain high on the list of leading findings in U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) inspections. In this web seminar, we will examine real-world examples of some of the top 10 inspection findings from the Annual BIMO Inspection Metrics, and discuss appropriate corrective and preventive actions (CAPAs), equipping learners with solutions to avoid common pitfalls and ultimately avoid inspection findings in the future. Correct conduct according to GCP will be discussed and lessons learned applied to help prevent these findings from occurring again. Learners are encouraged to share their experiences as participants discuss methods and tools to aid in compliance through appropriate techniques for ICH-GCP compliance. Tools will be provided to assist clinical research personnel in their efforts to be ICH-GCP compliant. \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eCritically assess the number of major and critical Annual BIMO inspection findings\u003c\/li\u003e \u003cli\u003eProvide examples of the Annual BIMO top inspection findings\u003c\/li\u003e \u003cli\u003eDiscuss how to prevent major and critical inspection findings\u003c\/li\u003e \u003cli\u003eApply the right corrective actions to resolve the major and critical inspection findings\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003ePrincipal Investigators\u003c\/li\u003e \u003cli\u003eCompliance Personnel\u003c\/li\u003e \u003cli\u003eClinical Research Coordinators\u003c\/li\u003e \u003cli\u003eClinical Research Associates\/Monitors\u003c\/li\u003e \u003cli\u003eRegulatory Affairs Professionals\u003c\/li\u003e \u003cli\u003eTrainers and Educators\u003c\/li\u003e \u003cli\u003eInvestigators\u003c\/li\u003e \u003cli\u003eAuditors and Inspectors\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eJanet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P. \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 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#: 0778-0000-23-011-L99-P. Released: 5\/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\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375371706733,"sku":"BI17455","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/current-fda-and-ema-inspection-findings-lessons-learned-2026-10-01","provider":"Barnett International ","version":"1.0","type":"link"}