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

Cases in Advanced GCP: A Problem-Solving Practicum

Upcoming Courses
Course #: BI11964
April 7, 2015
12:00 PM - 3:00 PM Eastern
Course #: BI12056
July 21, 2015
12:00 PM - 3:00 PM Eastern

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


This course will be taught by one of the following instructors:

Nikki Christison, B.S., C.C.R.A.

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

Click here for complete trainer biographies 

Registration Fees


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.