{"title":"FDA and MHRA: Annual GCP Inspection Findings","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\n\u003cp\u003eThe\nUK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the U.S.\nFood and Drug Administration (FDA) are two of the most exacting regulatory\nauthorities in the world. Their specialist inspectors are highly trained to\nidentify problems, deviations and discrepancies in clinical research. One of\nthe best ways to learn about the inspectorate and its areas of focus is to\nconsider the inspection findings which they have made. This web seminar will\nbring learners up-to-date on the current findings of the MHRA and FDA, which\nareas cause the regulators the most concern, and how they interpret the\nregulations and guidance to which they hold researchers accountable. \u003c\/p\u003e\n\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\n\u003cul type=\"disc\"\u003e\n\u003cli\u003eDescribe the remit of the MHRA and FDA\u003c\/li\u003e\n\u003cli\u003eExplain the main areas of concern to\n     the MHRA and FDA\u003c\/li\u003e\n\u003cli\u003eIdentify the most common and most\n     significant findings being written by the MHRA and FDA\u003c\/li\u003e\n\u003cli\u003eDescribe where the MHRA and FDA\n     apply enforcement discretion\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\n\u003cul type=\"disc\"\u003e\n\u003cli\u003eClinical Researchers from Industry, Academia and\n     CROs\u003c\/li\u003e\n\u003cli\u003eQuality Assurance Professionals from\n     Industry, Academia and CROs\u003c\/li\u003e\n\u003cli\u003ePersonnel with an interest in the\n     quality of clinical research\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"header-block-grey\"\u003eInstructor\u003cspan\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"bold-italic\"\u003eThe course will be led by one of the following\ninstructors:\u003c\/p\u003e\n\u003cp\u003eElizabeth\nRonk Nelson, M.P.H. \u003c\/p\u003e\n\u003cp\u003eVaska Tone \u003c\/p\u003e\n\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003cspan\u003e\u003ca href=\"https:\/\/stage.barnettinternational.com\/instructor-biographies\" title=\"Click here for complete trainer biographies\"\u003e\u003cspan\u003eClick here for complete trainer\nbiographies\u003c\/span\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\n\u003cp\u003e$835\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eIncludes up to 20\nparticipants at one site. All participants (up to 20) are eligible for\n“Certificates of Attendance,” and accreditation, provided that accreditation\nrequirements are met. For groups larger than 20 or for additional sites, please\ncall +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eBarnett International is accredited by the\nAccreditation Council for Pharmacy Education as a provider of continuing\npharmacy education.  Participants will\nreceive 3 hours (0.3 CEUs) of continuing education credit for full\nparticipation, including the completion of a pre-test, post-test, and program\nevaluation.  Barnett International will\nissue a receipt of completion for earned CEUs within three weeks of program\ncompletion.  ACPE#: 0778-0000-18-028-L01-P.\nReleased: 4\/18. \u003c\/span\u003e\u003c\/p\u003e\n\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003e\u003cspan\u003eHold\nthis course at your company! For more information, contact Naila Ganatra at +1\n215.413.2471.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e","products":[],"url":"https:\/\/www.barnettinternational.com\/collections\/fda-and-mhra-annual-gcp-inspection-findings.oembed","provider":"Barnett International ","version":"1.0","type":"link"}