Statistical Concepts for Non-Statisticians
April 13-14, 2015
Philadelphia, PA
Comprehensive Monitoring for Medical Devices
April 8-10, 2015
San Francisco, CA
Monitoring Clinical Drug Studies: Beginner
April 14-16, 2015
San Diego, CA

Comprehensive Monitoring for Medical Devices

Upcoming Courses

Course #: SDOF0415
April 8-10, 2015
Hilton San Francisco Union Square
San Francisco, CA

Course #: SDOB0615
June 16-18, 2015
Metro Meeting Centers - Boston
Boston, MA
Take advantage of our $1,695.00 price by registering early!
* After May 14, costs are $1,895.00.

Course #: SDOA0715
July 28-30, 2015
The Hub Meeting Center - CityView
Philadelphia, PA
Take advantage of our $1,695.00 price by registering early!
* After June 25, costs are $1,895.00.

Course Description 

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.  

Learning Objectives 

  • 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 3 ways devices are characterized 
  • Prepare and conduct a pre-investigation visit, an investigator’s meeting, an initiation visit, a periodic 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 audit 
Who Should Attend

  • CRAs with 1-2 years of experience, 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. 

The course will be led by one of the following instructors: 

Gary B. Freeman, M.S., C.C.R.A. 

Click here for complete trainer biographies 

Course Outline 

Day 1: 8:30 a.m. – 5:00 p.m. 

  • Introduction to the FDA and the Medical Device Approval Process: Introduction to the FDA; ICH overview; definitions; medical device regulatory processes 
  • US Good Clinical Practices: Concept of Good Clinical Practices; US GCP – sponsor, investigator and IRB obligations; overview of monitor’s responsibilities 
  • IRB Approval & Informed Consent Process: IRB application for approval; approval process – initial and ongoing; informed consent process and documentation; HIPAA authorization 
  • 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 

Day 2: 8:30 a.m. – 5:00 p.m. 

  • Study Documentation: Sponsor files; investigator files; source documentation; case report forms; communication 
  • Monitoring: Roles and responsibilities of the monitor during periodic visits; source document verification; case report form review and correction onsite; data retrieval and correction; document retrieval; protocol, investigational plan and GCP deviations;
    monitoring documentation

Day 3:  8:30 a.m. – 5:00 p.m. 

  • Device Accountability: Sponsor responsibilities as they relate to device accountability; investigator responsibilities as they relate to device accountability 
  • Close-out Visits: Reasons for a closeout visit; roles and responsibilities of the monitor during a closeout visit; investigator responsibilities after closeout 
  • 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 
  • FDA Audits: Purpose, types and mechanics of FDA audits; common audit findings; FDA actions following an audit; the ‘dos’ and ‘don’ts’ in the event of an FDA audit 

Interactive Activities 

  • Monitoring Skills – Hands-On Simulation 
  • Monitor Group Discussions – Includes Case Studies for Monitor Visits, Device Accountability, Informed Consent Review, and Monitoring Priorities 
  • The Device Approval Process – Classifying Devices and Determining Pathways to Marketing 
  • Selecting Study Sites 
  • Coaching Tips for an FDA Inspection 
Registration Fees

Registration 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. 

Special 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. 

Click here for our seminar cancellation policy 

Accreditation Information

ACPE LogoBarnett 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# 0778-0000-14-006-L01-P. Released: 2/14. 

This continuing nursing education activity was approved by the New Jersey State Nurses Association, an accredited approver by the American Nurses Credentialing Center's Commission on Accreditation. 

Approval Number: 7464-2/14-16.  21.25 Contact Hours  

Participants will receive 21.25 hours of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  

Hold this course at your company! 

For more information, contact Naila Ganatra at (215) 413-2471.