{"title":"FDA Pre-Approval Inspection Readiness: Clinical Investigators","description":"\u003cp\u003e\u003cimg title=\"Course Description\" border=\"0\" alt=\"Course Description\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/CourseDescription.jpg?n=8101\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eThere is often fear and a mystique surrounding the process of an FDA site inspection. This workshop will include insights from a former FDA medical officer on the importance of Good Clinical Practices (GCPs) to help ensure sites are prepared for the FDA. Your instructor will show learners exactly what the FDA is looking for during a site inspection, and why these inspections are critical to both the drug\/device approval process. This workshop will include presentations, discussions, and problem-solving using case studies applicable to both drug and device studies. Exercises are designed to prepare you for the FDA’s arrival, anticipate FDA issues and concerns, and ensure success. Learners are encouraged to bring their questions and join in interactive discussions. Together we will de-mystify the process of FDA audits and help you learn how to ready your site for the FDA. \u003c\/p\u003e\n\u003cp\u003e\u003cimg title=\"Learning Objectives\" border=\"0\" alt=\"Learning Objectives\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/LearningObjectives.jpg?n=1786\"\u003e\u003c\/p\u003e\n\u003cul style=\"padding-left: 20px;\" class=\"Abstract\"\u003e\n\u003cli\u003eConclude investigational sites are better prepared for GCP\/FDA inspections\u003c\/li\u003e\n\u003cli\u003eAnticipate FDA GCP expectations for both drugs and medical devices\u003c\/li\u003e\n\u003cli\u003eRecognize sponsor\/company\/investigator responsibilities applicable to FDA submission\u003c\/li\u003e\n\u003cli\u003eApply basic concepts to assess whether companies\/sponsors follow current FDA risk-based monitoring\/auditing guidances\u003c\/li\u003e\n\u003cli\u003eHow to think like a regulator\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Who Should Attend\" border=\"0\" alt=\"Who Should Attend\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/WhoShouldAttend.jpg?n=5464\"\u003e\u003c\/p\u003e\n\u003cul style=\"padding-left: 20px;\" class=\"Abstract\"\u003e\n\u003cli\u003eClinical Research Professionals\u003c\/li\u003e\n\u003cli\u003eClinical Research Coordinators\u003c\/li\u003e\n\u003cli\u003eClinical Research Associates\u003c\/li\u003e\n\u003cli\u003eInvestigators and Site Personnel\u003c\/li\u003e\n\u003cli\u003eIRB\/Ethic Committee Members\u003c\/li\u003e\n\u003cli\u003eProject Managers\u003c\/li\u003e\n\u003cli\u003eQuality Assurance Personnel\u003c\/li\u003e\n\u003cli\u003eRegulatory Affairs Professionals\u003c\/li\u003e\n\u003cli\u003eAuditors\/Monitors\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Instructor\" border=\"0\" alt=\"Instructor\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/Instructor.jpg?n=4140\"\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003e\u003ci\u003eThe course will be led by one of the following instructors:\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eJerri Barden Perkins, M.D.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cb\u003e\u003ci\u003e\u003ca title=\"Click here for complete trainer biographies\" href=\"\/pages\/instructor-biographies\" style=\"color: rgb(0, 0, 255);\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cimg title=\"Course Outline\" border=\"0\" alt=\"Course Outline\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/CourseOutline.jpg?\u0026lt;p\u0026gt;\u0026lt;b\u0026gt;\u0026lt;i\u0026gt;\u0026lt;font%20size=\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cb\u003e\u003ci\u003eDay 1: 8:30 a.m. – 5:00 p.m.\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cul style=\"padding-left: 20px;\" class=\"Abstract\"\u003e\n\u003cli\u003e\u003cb\u003eHow to Prepare Your Site for an FDA Inspector\u003c\/b\u003e\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eFraud Detection: \u003c\/b\u003eHow Does FDA find Fraud?\u003c\/li\u003e\n\u003cli\u003e\u003cb\u003eInvestigator\/Sponsor Responsibility for Clinical Investigation including 1572\u003c\/b\u003e\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eHands-on Exercise: \u003c\/b\u003eMock FDA Audit Role Play\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"Abstract\"\u003e\u003cb\u003e\u003ci\u003eDay 2: 8:30 a.m. – 5:00 p.m.\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cul style=\"padding-left: 20px;\" class=\"Abstract\"\u003e\n\u003cli\u003e\u003cb\u003eRisk-Based Monitoring\/Auditing\u003c\/b\u003e\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003e483s and FDA Warning Letters: \u003c\/b\u003eWhat can be Learned?\u003c\/li\u003e\n\u003cli\u003e\u003cb\u003eCurrent FDA Actions Regarding IRB\/Ethics Responsibilities\u003c\/b\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cb\u003eErrors in GCP and How to Prevent Clinical Nightmares\u003c\/b\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Interactive Activities\" border=\"0\" alt=\"Interactive Activities\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/InteractiveActivities.jpg?n=4477\"\u003e\u003c\/p\u003e\n\u003cul style=\"padding-left: 20px;\" class=\"Abstract\"\u003e\n\u003cli\u003eTeam Review of Warning Letters with group discussion\u003c\/li\u003e\n\u003cli\u003eTeam Role Play in Mock Audit\u003c\/li\u003e\n\u003cli\u003eQuestions for each participant to be answered independently with group discussion on answers\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Registration Fees\" border=\"0\" alt=\"Registration Fees\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/RegistrationFees.jpg?n=6142\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eRegistration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eSpecial rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cb\u003e\u003ci\u003e\u003ca title=\"Click here for our seminar cancellation policy\" href=\"https:\/\/stage.barnettinternational.com\/EducationalServices\/SeminarFAQs.aspx\" style=\"color: rgb(0, 0, 255);\"\u003eClick here for our seminar cancellation policy\u003c\/a\u003e\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cimg title=\"Accreditation Information\" border=\"0\" alt=\"Accreditation Information\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/AccreditationInformation.jpg?n=7031\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cimg title=\"ACPE Logo\" border=\"0\" alt=\"ACPE Logo\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services_-_Under_Construction\/ACPE%20Logo.JPG\"\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 15 hours (1.5 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# 0778-0000-15-028-L01-P. Released 2\/15.\u003c\/p\u003e\n\u003cp align=\"center\" style=\"color: rgb(0, 0, 255);\"\u003e\u003cb\u003e\u003ci\u003eHold this course at your company!\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp align=\"center\" style=\"color: rgb(0, 0, 255);\"\u003e\u003cb\u003e\u003ci\u003eFor more information, contact Naila Ganatra at (215) 413-2471.\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e","products":[],"url":"https:\/\/www.barnettinternational.com\/collections\/fda-pre-approval-inspection-readiness-clinical-investigators.oembed","provider":"Barnett International ","version":"1.0","type":"link"}