{"title":"The FDA Medical Device Pre-Submission Package and FDA Meetings","description":"\u003cp\u003e\u003cimg title=\"Course Description\" alt=\"Course Description\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/CourseDescription.jpg?n=5553\" border=\"0\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eThe FDA Medical Device Pre-Submission program is intended for companies to use in order to obtain FDA feedback on future applications prior to their submission. The applications include Investigational Device Exemptions (IDEs), Premarket Approvals (PMAs), Humanitarian Device Exemptions (HDEs), and Premarket Notifications (510(k)s). This program allows the FDA to provide advice to applicants who are developing clinical and nonclinical testing protocols which are submitted with the company’s application. The program also allows the FDA to work with applicants from medical device concept to market. This web seminar will provide learners with information about how to prepare for and conduct various FDA meetings, specifically addressing the types of applications that companies file with the FDA.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cimg title=\"Learning Objectives\" alt=\"Learning Objectives\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/LearningObjectives.jpg?n=4499\" border=\"0\"\u003e\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003eNavigate the FDA Pre-Submission program\u003c\/li\u003e\n\u003cli\u003eDescribe the various FDA Pre-Submission meetings\u003c\/li\u003e\n\u003cli\u003ePrepare an FDA Pre-Submission package\u003c\/li\u003e\n\u003cli\u003ePrepare for and conduct FDA meetings\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Who Should Attend\" alt=\"Who Should Attend\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/WhoShouldAttend.jpg?n=7655\" border=\"0\"\u003e\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003eRegulatory Affairs Personnel \u003c\/li\u003e\n\u003cli\u003eQuality Assurance Personnel\u003c\/li\u003e\n\u003cli\u003eClinical Personnel\u003c\/li\u003e\n\u003cli\u003eResearch Personnel\u003c\/li\u003e\n\u003cli\u003ePersonnel who require a general understanding of the FDA's Pre-Submission program\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Instructor\" alt=\"Instructor\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/Instructor.jpg?n=9798\" border=\"0\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eAlbert A. Ghignone, M.S., R.A.C.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003ca title=\"Click here for complete trainer biographies\" href=\"https:\/\/stage.barnettinternational.com\/instructor-biographies\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cfont color=\"#800080\"\u003eClick here for complete trainer biographies\u003c\/font\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/a\u003e \u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cimg title=\"Registration Fees\" alt=\"Registration Fees\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/RegistrationFees.jpg?n=5717\" border=\"0\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e$795\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eIncludes up to 20 participants at one site. 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 sites, please call 1-800-856-2556 for pricing.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cimg title=\"Accreditation Information\" alt=\"Accreditation Information\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/AccreditationInformation.jpg?n=3445\" border=\"0\"\u003e\u003cbr\u003e\u003cbr\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 3 hours (0.3 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will mail ACPE statements within three weeks of program completion.  ACPE#: 0778-0000-14-044-L01-P. Released: 3\/14. \u003c\/p\u003e\n\u003cp align=\"center\" class=\"Abstract\"\u003e\u003cfont color=\"#0000ff\"\u003e\u003cstrong\u003eHold this course at your company! \u003c\/strong\u003e\u003cstrong\u003eFor more information, contact Naila Ganatra at (215) 413-2471.\u003c\/strong\u003e\u003c\/font\u003e \u003c\/p\u003e\n\u003cp align=\"left\" class=\"Abstract\"\u003e \u003c\/p\u003e\n\u003cp align=\"left\" class=\"Abstract\"\u003e \u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e","products":[],"url":"https:\/\/www.barnettinternational.com\/collections\/the-fda-medical-device-pre-submission-package-and-fda-meetings.oembed","provider":"Barnett International ","version":"1.0","type":"link"}