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UPCOMING LIVE SEMINARS
 
Comprehensive Monitoring for Medical Devices
September 13-15, 2016
Boston, MA
Effectively Writing Clinical Trial Protocols
September 14-15, 2016
Boston, MA
Clinical Project Management: Advanced
September 6-7, 2016
San Diego, CA
Monitoring Clinical Drug Studies: Beginner
September 6-8, 2016
San Francisco, CA







Medical Device GCP Overview

Upcoming Courses

Course #: SD8B1216
December 6-7, 2016
Metro Meeting Centers - Boston
Boston, MA
Take advantage of our $1,595.00 price by registering early!
* After November 4, costs are $1,795.00.

Course Description

This course provides information across the full range of medical device clinical trial activities. It is an ideal source of information for those new to clinical research and those requiring information specifically relating to regulatory and practical aspects of medical device clinical research.

Learning Objectives

  • Navigate the regulatory pathways for medical devices in the U.S
  • Explore practical aspects of investigator and monitor selection
  • Comply with the fundamentals of Good Clinical Practice (GCP)
  • Explore practical aspects of conducting international clinical trials
Who Should Attend

  • Clinical Research Associates who want a greater understanding of the medical device clinical trial process and their role in it
  • Clinical Project Managers who are taking on a wider range of responsibilities and need to gain a greater understanding of the regulatory and practical issues involved in medical device clinical trials
  • Regulatory Affairs Professionals who may be new to the device industry or new to the clinical trials process
  • Clinical Investigators and Clinical Research Coordinators interested in gaining a broader understanding of their role and responsibilities and how these tasks relate to the overall research process
Instructor

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.

  • Medical Device and Good Clinical Practices
  • Medical Device and Regulatory Requirements
  • Clinical Research Team: Role and Responsibilities

Day 2: 8:30 a.m. – 5:00 p.m.

  • Clinical Study Protocol Elements and Device Accountability
  • Role of Institutional Review Board (IRB) and Informed Consent
  • Principles of Ethics and Quality Control

Interactive Activities

  • Clinical and Data Management Discussions
  • Review of Regulatory Documents

 

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 15 hours (1.5 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# 0778-0000-16-035-L01-P. Released: 12/16.

Hold this course at your company!

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