{"title":"FDA Pre-Approval Inspection Readiness: Sponsors and CROs","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\n\u003cp\u003eThis\ncourse will prepare participants for FDA pre-approval inspections, for\npharmaceuticals, biologics, or medical devices. Sponsor\/CRO inspections will be\naddressed. Not only will we review the documents sponsors and CROs need to\nprovide for a GCP inspection, but also the FDA’s rationale for different lines\nof questioning. Data shows prepared sponsors and CROs are more likely to have a\nsuccessful inspection.\u003c\/p\u003e\n\u003cp\u003eThe course will focus on a\ndetailed review of the FDA Compliance Programs. For each topic in the\nCompliance Program, the questions the sponsor should expect, different ways\nquestioning will be completed, and the types of documentation to be provided to\nreadily satisfy FDA requests will be outlined. The information covered can be\nused to prepare Inspection Management teams and Subject Matter Experts.\u003c\/p\u003e\n\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\n\u003cul type=\"disc\"\u003e\n\u003cli\u003eUnderstand what to prepare\/FDA inspection\n     logistics\u003c\/li\u003e\n\u003cli\u003eIdentify what you can do on site to\n     prepare for an FDA inspection\u003c\/li\u003e\n\u003cli\u003eLearn what to expect and provide\n     during an FDA inspection\u003c\/li\u003e\n\u003cli\u003eApply learning to real-life\n     situations by inspecting records using FDA techniques\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\u003eDirectors and Managers, Clinical Operations\u003c\/li\u003e\n\u003cli\u003eQuality Assurance Professionals\u003c\/li\u003e\n\u003cli\u003eRegulatory Affairs Professionals\u003c\/li\u003e\n\u003cli\u003eClinical Research Associates\u003c\/li\u003e\n\u003cli\u003eProject Managers\u003c\/li\u003e\n\u003cli\u003ePersonnel responsible for inspection\n     preparation, representation\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\u003eJeanne\nMorris, B.S., MT (ASCP)\u003c\/p\u003e\n\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003cspan\u003e\u003ca href=\"https:\/\/www.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\"\u003eCourse Outline\u003c\/p\u003e\n\u003cp class=\"bold-italic\"\u003eDay One: 8:30 a.m. – 5:00 p.m.\u003c\/p\u003e\n\u003cul type=\"disc\"\u003e\n\u003cli\u003e\n\u003cspan class=\"bold\"\u003e\u003cspan\u003eRegulatory Inspections of Sponsors\u003c\/span\u003e\u003c\/span\u003e\u003cb\u003e\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e\u003c\/b\u003e\n\u003c\/li\u003e\n\u003cli\u003e\u003cspan class=\"normal-text\"\u003eThe standards\u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan class=\"normal-text\"\u003eLogistics and pre-inspection activities\u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan class=\"normal-text\"\u003eSponsor\/CRO inspections\u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\n\u003cspan class=\"normal-text\"\u003ePost inspection\u003c\/span\u003e\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\u003cspan class=\"normal-text\"\u003eCase study\u003c\/span\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp class=\"header-block-grey\"\u003eInteractive Activities\u003c\/p\u003e\n\u003cul type=\"disc\"\u003e\n\u003cli\u003eInspect sample records from the sponsor\/CRO using\n     the same techniques as the FDA\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\n\u003cp\u003eRegistration\nfees include assorted breakfast items that will be available each day ½ hour\nprior to the start of the seminar. Also included is a Networking Lunch that\nwill be served each training day.\u003c\/p\u003e\n\u003cp\u003eSpecial rates are available for\nmultiple attendees from the same organization. \nContact Melissa Dolen at 781-972-5418 to discuss your options and take\nadvantage of the savings.     \u003cspan\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003cspan\u003e\u003ca href=\"\/pages\/faqs\" title=\"Click here for our seminar cancellation policy\"\u003e\u003cspan\u003eClick here for our seminar\ncancellation policy\u003c\/span\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\n\u003cp\u003eBarnett International is accredited by the\nAccreditation Council for Pharmacy Education as a provider of continuing\npharmacy education.  Participants will\nreceive 7 hours (0.7 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#: 0778-0000-19-030-L01-P.\nReleased: 4\/19. \u003c\/p\u003e\n\u003cp class=\"header-block-grey\"\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\u003cb\u003e\u003cspan\u003e\u003c\/span\u003e\u003c\/b\u003e\u003c\/p\u003e","products":[],"url":"https:\/\/www.barnettinternational.com\/collections\/fda-pre-approval-inspection-readiness-sponsors-and-cros.oembed","provider":"Barnett International ","version":"1.0","type":"link"}