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Quality Systems: A Controlled Approach to GCP Compliance

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

Course Description

A Quality Systems approach to establishing and maintaining regulatory compliance allows sponsors to better leverage their resources and Clinical Investigators to meet their obligations for clinical research oversight. This web seminar will review the elements of a Quality System at the Clinical Investigator site and how it functions to proactively control site-level noncompliance.

Learning Objectives

  • Discuss an overview of sponsor and Clinical Investigator responsibilities
  • Explain how to identify the active elements of a functional Quality System at the clinical research site
  • Discuss how implementation of a Quality System can assist in the requirements for meeting obligations of sponsors and Clinical Investigators
  • Determine how Quality System overlaps with FDA Guidance
  • Examine recent compliance concerns and how applying the Quality System framework at the site level can address them

Who Should Attend

  • Directors of Clinical Operations at clinical research sites
  • Clinical Principal Investigators
  • Clinical Research Coordinators
  • Clinical Research Associates
  • Project Managers
  • All Clinical Research Personnel involved in selecting and/or overseeing clinical research sites

Instructor

Elizabeth Ronk Nelson, M.P.H.

Click here for complete trainer biographies 

Registration Fees

$695

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 2 hours (0.2 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#: 0778-0000-12-023-L01-P.  Released: 4/12. 

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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Informed Consent Content & Process Requirements for Biobanking Studies 

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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)