{"product_id":"10-week-comprehensive-monitoring-for-medical-devices-2027-01-08","title":"10-Week Comprehensive Monitoring for Medical Devices","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThis online 10-Week program 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 devices 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\u003ePrior to the start of the course, participants will receive their login credentials and links to access and download the many class resources and class meeting links. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass both a mid-term and final exam. Upon completion of the exams, CEU certificates will be provided.\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 close-out 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\"\u003eCourse Outline\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eModule 1: Introduction to the FDA and the Medical Device Approval Process: Introduction to the FDA; ICH overview; definitions; medical device regulatory processes\u003c\/li\u003e \u003cli\u003eModule 2: US Good Clinical Practices: Concept of Good Clinical Practices; US GCP - sponsor, investigator and IRB obligations; overview of monitor's responsibilities\u003c\/li\u003e \u003cli\u003eModule 3: IRB Approval \u0026amp; Informed Consent Process: IRB application for approval; approval process - initial and ongoing; informed consent process and documentation; HIPAA authorization\u003c\/li\u003e \u003cli\u003eModule 4: Pre-Study Processes: Determining the sponsor's investigator\/site needs; pre-investigation and confidentiality agreement; investigator\/site selection; contracts\/ agreements; investigator's meeting; initiation visit; recruitment and advertising\u003c\/li\u003e \u003cli\u003eModule 5: Study Documentation: Sponsor files; investigator files; source documentation; case report forms; communication\u003c\/li\u003e \u003cli\u003eModule 6: Monitoring: Roles 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\/li\u003e \u003cli\u003eModule 7: Device Accountability: Sponsor responsibilities as they relate to device accountability; investigator responsibilities as they relate to device accountability\u003c\/li\u003e \u003cli\u003eModule 8: Close-out Visits: Reasons for a closeout visit; roles and responsibilities of the monitor during a closeout visit; investigator responsibilities after closeout\u003c\/li\u003e \u003cli\u003eModule 9: Managing and Reporting Adverse Events: Adverse event terminology; variations in adverse event reporting and documentation; sponsor obligations relating to adverse event reporting; investigator obligations relating to adverse event reporting\u003c\/li\u003e \u003cli\u003eModule 10: FDA Inspections: Purpose, types and mechanics of FDA inspections; common audit findings; FDA actions following an inspection; review of 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 GCP \u003c\/li\u003e\u003c\/ul\u003e\u003cp\u003eNOTE: This course is for individual registrants only and does not allow for group training.\u003c\/p\u003e\u003cp class=\"abstract\"\u003e\u003cspan class=\"bold\"\u003eWhat participants say about Barnett's 10-Week courses ...\u003c\/span\u003e\u003c\/p\u003e\u003cp\u003e\"The course has been so incredibly helpful thus far...I look forward to Thursday evenings!\"\u003c\/p\u003e\u003cp\u003e\"This class exceeded my expectations of an online learning experience. The instructor was knowledgeable, came equipped with great examples to keep the class interesting and is a strong presenter. Thank you!\"\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003e\u003cb\u003e\u003ci\u003eThe course will be led by one of the following instructors:\u003c\/i\u003e\u003c\/b\u003e\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\"\u003e\u003cspan class=\"purple-link\"\u003e\u003cb\u003e\u003ci\u003eCourse Length and Time\u003c\/i\u003e\u003c\/b\u003e\u003c\/span\u003e\u003c\/p\u003e\u003cp\u003e10 weeks for 3 hours each week.\u003c\/p\u003e\u003cp\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$1,795 by Early Bird Deadline \u003c\/p\u003e\u003cp\u003e$1,995 after Early Bird Deadline\u003c\/p\u003e\u003cp\u003eThis course is for individual registrants only and does not allow for group training.\u003c\/p\u003e\u003cp\u003eAll participants are eligible for \"Certificates of Attendance,\" and accreditation, provided that accreditation requirements are met.\u003c\/p\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 30 hours (3.0 CEUs) of continuing education credit for full participation, including the completion of a mid-term exam, final exam, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-25-025-L99-P. Released: 2\/25.\u003cbr\u003e\u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.\u003c\/span\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53474450604397,"sku":"BI17616","price":1995.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/10-week-comprehensive-monitoring-for-medical-devices-2027-01-08","provider":"Barnett International ","version":"1.0","type":"link"}