SEARCH


UPCOMING LIVE SEMINARS
 






Cases in Advanced GCP: A Problem-Solving Practicum

Upcoming Courses
Course #: BI11682
June 16, 2014
9:00 AM - 12:00 PM Eastern
$795.00

Course Description

This application-based web seminar covers advanced concepts and challenges encountered in the application of Good Clinical Practice (GCP). During this highly interactive course, participants will review and discuss cases that include GCP challenges in topic areas such as IRB/IEC approval, informed consent, drug accountability and reconciliation, SUSAR submissions, communications with ethics committees and health authorities, as well as the management of investigational product. Cases are based on actual industry examples, and participants are expected to solve cases by applying Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) principles, which are briefly reviewed.

Learning Objectives

  • Apply your understanding of the GCP standards most critical to core clinical research job functions
  • Explain the role of Quality Systems in the GCP environment
  • Apply GCP through critical thinking in the context of real-world clinical research scenarios and simulations
  • Explain the concepts of RCA and CAPA to improve site and sponsor performance and compliance

Who Should Attend

This course is recommended for experienced:

  • Clinical Quality Assurance Professionals
  • Clinical Research Associates
  • Project Managers
  • Investigators
  • Study Coordinators
  • GCP-focused Regulatory Affairs Professionals
  • Clinical Operations Professionals

Instructor

Jeanne Morris, B.S., MT (ASCP)

Click here for complete trainer biographies 

Registration Fees

$795

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 3 hours (0.3 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#: 0778-0000-14-050-L01-P. Released: 3/14. 

Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471. 

 

 

 

FOLLOW US ON: 

LinkedIn twitter Facebook 


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. 


BARNETT CATALOG The Barnett Catalogue is your comprehensive guide to the myriad live, web, and custom training opportunities offered throughout the year. 

Jan - July 2014 Edition

Winter CatalogDownload Today!  

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

BCP Cover

Download Today! 

 

 

 


 

DVD IconWEB SEMINAR ARCHIVE 

 View Catalog of Offerings   

New Titles added every month! 
Course Alumni Save 50% 


Live SeminarLIVE SEMINARS

Monitoring Clinical Drug Studies: Intermediate 

Informed Consent Content & Process Requirements for Biobanking Studies 

Auditing Techniques for Clinical Research Professionals 


Web SeminarWEB SEMINARS

10-Week CRA & CRC Beginner Program  

Trial Master File (TMF) for Sponsors: Set-Up and Maintenance 

Use of Notes to File in Clinical Trial Essential Documentation 

10-Week Clinical Research Associate (CRA) On-Boarding Program  


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)