Comprehensive Monitoring for Medical Devices Course is organized by Barnett International and will be held from Dec 03 - 05, 2019 at Hilton San Francisco Union Square, San Francisco, California, United States of America.
Who Should Attend:
CRAs 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
Barnett 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.
This 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.
• Discuss the FDA regulations pertaining to clinical research and describe the ICH structure and function
• Define the common terms used in the field of device clinical research and identify the three ways devices are characterized
• Prepare and conduct a pre-investigation visit, an investigator’s meeting, an initiation visit, a periodic visit, and a closeout visit
• List the types of regulatory and study documents required for the sponsor and for the investigator
• List both the sponsor’s and investigator’s obligations as they relate to device accountability
• Describe the differences between adverse events, adverse device effects, and unanticipated adverse device effects
• Discuss the “dos and don’ts” in the event of an FDA inspections
|Contact No. :||781-972-5400
|Registration Type||End Date||Price|
|Commercial - Early Fee||01 Nov,2019||USD 1795.00|
|Commercial - Conference Fee||02 Dec,2019||USD 1995.00|
|Academic Fee||02 Dec,2019||USD 1595.00|