{"product_id":"comprehensive-monitoring-for-medical-devices-2026-10-13","title":"Comprehensive Monitoring for Medical Devices","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThis course provides an in-depth overview of the medical device development process and the role of the Clinical Research Associate (CRA) in managing and monitoring medical device studies. This course is ideal for CRAs new to the device industry, as well as experienced CRAs who are transitioning from monitoring drug studies to monitoring device studies. \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDiscuss the FDA regulations pertaining to clinical research and describe the ICH structure and function\u003c\/li\u003e \u003cli\u003eDefine the common terms used in the field of device clinical research and identify the three ways devices are characterized \u003c\/li\u003e \u003cli\u003ePrepare and conduct a pre-investigation visit, an investigator's meeting, an initiation visit, a periodic visit, and a closeout visit\u003c\/li\u003e \u003cli\u003eList the types of regulatory and study documents required for the sponsor and for the investigator\u003c\/li\u003e \u003cli\u003eList both the sponsor's and investigator's obligations as they relate to device accountability\u003c\/li\u003e \u003cli\u003eDescribe the differences between adverse events, adverse device effects, and unanticipated adverse device effects \u003c\/li\u003e \u003cli\u003eDiscuss the FDA inspection process and what can be learned from issues warning letters\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e\u003cli\u003eCRAs with one to two years of experience, and Engineers and other Device Industry Professionals responsible for the placement and monitoring of clinical trials, who want a practical, hands-on introduction to monitoring medical device studies according to Good Clinical Practice\u003c\/li\u003e\u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003eThe course will be led by one of the following instructors:\u003c\/p\u003e\u003cp\u003eHeather Marshall, M.S.N., B.S.N., R.N.\u003c\/p\u003e\u003cp\u003eShana Zink, B.S., C.C.R.A.\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"https:\/\/www.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\"\u003eCourse Outline\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003eDay One\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eIntroduction to the FDA and the Medical Device Approval Process:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eIntroduction to the FDA; ICH overview; definitions; medical device regulatory processes\u003c\/span\u003e\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eUS Good Clinical Practices:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eConcept of Good Clinical Practices; US GCP - sponsor, investigator and IRB obligations; overview of monitor's responsibilities\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eIRB Approval \u0026amp; Informed Consent Process:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eIRB application for approval; approval process - initial and ongoing; informed consent process and documentation; HIPAA authorization\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003ePre-Study Processes:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eDetermining the sponsor's investigator\/site needs; preinvestigation and confidentiality agreement; investigator\/site selection; contracts\/agreements; investigator's meeting; initiation visit; recruitment and advertising\u003c\/span\u003e \u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"bold-italic\"\u003eDay Two \u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eStudy Documentation:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eSponsor files; investigator files; source documentation; case report forms; communication\u003c\/span\u003e\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eMonitoring:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eRoles and responsibilities of the monitor during periodic visits; source document verification; case report form review in EDC; data retrieval and correction; document retrieval; protocol, investigational plan and GCP deviations; monitoring documentation\u003c\/span\u003e \u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"bold-italic\"\u003eDay Three \u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eDevice Accountability: \u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eSponsor responsibilities as they relate to device accountability; investigator responsibilities as they relate to device accountability\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eClose-out Visits:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eReasons for a closeout visit; roles and responsibilities of the monitor during a closeout visit; investigator responsibilities after closeout\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eManaging and Reporting Adverse Events:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eAdverse event terminology; variations in adverse event reporting and documentation; sponsor obligations relating to adverse event reporting; investigator obligations relating to adverse event reporting\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eFDA Inspections:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003ePurpose, types and mechanics of FDA inspections; common audit findings; FDA actions following an inspection; review of warning letters\u003c\/span\u003e \u003c\/li\u003e \u003c\/ul\u003e\u003cp\u003e \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eInteractive Activities\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eMonitoring Skills - Hands-On Simulation\u003c\/li\u003e \u003cli\u003eMonitor Group Discussions - Includes Case Studies for Monitor Visits, Device Accountability, Informed Consent Review, and Monitoring Priorities\u003c\/li\u003e \u003cli\u003eThe Device Approval Process - Classifying Devices and Determining Pathways to Marketing\u003c\/li\u003e \u003cli\u003eAssessing Adverse Events\u003c\/li\u003e \u003cli\u003eWarning Letter Lessons Learned\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e\u003cfont face=\"inherit\" size=\"-1\"\u003eThis course is for individual registrants only and does not allow for group training.\u003c\/font\u003e \u003c\/p\u003e\u003cdiv\u003e\u003cbr\u003e\u003c\/div\u003e\u003cdiv\u003e \u003cp\u003eSpecial rates are available for multiple attendees from the same organization. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for more information. Or email Customer Service at: customer.service@barnettinternational.com.\u003c\/p\u003e \u003cp\u003e\u003ca href=\"\/pages\/faqs\" title=\"Click here for our seminar cancellation policy\" style=\"font-family:inherit;font-size:inherit;text-align:inherit;text-transform:inherit;white-space:inherit;word-spacing:normal;\"\u003eClick here for our seminar cancellation policy\u003c\/a\u003e\u003cbr\u003e\u003c\/p\u003e \u003c\/div\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 22.5 hours (2.25 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#: 0778-0000-23-028-L99-P. Released: 3\/23. \u003c\/p\u003e\u003cp class=\"Normal\"\u003e \u003cspan class=\"bold\"\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.\u003c\/span\u003e\u003cb\u003e\u003c\/b\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375361417581,"sku":"SDOJ1026","price":1995.0,"currency_code":"USD","in_stock":true},{"title":"Academic","offer_id":53375361450349,"sku":"SDOJ1026-ACADEMIC","price":1575.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/comprehensive-monitoring-for-medical-devices-2026-10-13","provider":"Barnett International ","version":"1.0","type":"link"}