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Medical Device GCP Overview

Please check back later for this seminar's current schedule, or review our other live seminars for similar courses.

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

Albert A. Ghignone, M.S., R.A.C. 

Click here for complete trainer biographies

Course Outline 

Day 1: 8:30 a.m. – 5:00 p.m. 

  • Introduction to the FDA: History; law; definitions 
  • Medical Device Process: Three classes of device; 510(K); IDE; PMA 
  • Clinical Research Process: Types of clinical studies; clinical study controls; international studies; ICH process; guideline process 

Day 2: 8:30 a.m. – 5:00 p.m. 

  • ICH GCP: Sponsor obligations; investigator obligations; IRB/IEC obligations 
  • Monitoring: Five basic monitoring visits 
  • Adverse Device Experience: Expected; unexpected 
  • Data Management: Data entry; data query; validation 
  • FDA Bioresearch Monitoring Program: Site audits 

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 mail ACPE statements within three weeks of program completion.  ACPE# 0778-0000-13-036-L01-P. Released: 12/13. 

Hold this course at your company! 

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

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On-Demand GCP Refresher Training 

Too busy to attend a course? Our newly-released GCP eLearning course may be your solution!
For details on our scenario-based practical GCP application on-demand course, click here.


GCP for Investigators
 

Barnett’s scenario-based eLearning course is designed with the busy Principal Investigator in mind.  Based on real-life scenarios encountered by investigative site teams, this highly focused 7-module GCP training is designed to ensure comprehensive understanding of the key components of GCP.

For more details on this scenario-based eGCP program for investigators please click here. 


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Blended Curriculum Path for the CRA, CRC, and Project Manager

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Web SeminarWEB SEMINARS

10-Week CRA & CRC Beginner Program  

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PublicationsPUBLICATIONS

2012 GCP Question & Answer Guide Print Edition 

2012 Good Clinical Practice Question & Answer Guide Electronic Edition 

CFR/ICH GCP Reference Guide 2012 (Spiral Bound) 

CFR/ICH GCP Reference Guide 2012 (Perfect Bound) 

PAREXEL's Bio/Pharma R&D Statistical Sourcebook 2012/2013 (Hard Copy)