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FDA's Bioresearch Monitoring (BIMO) Program: Inspection of IRBs

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

Course Description

The FDA recently released its much-anticipated Compliance Program Guidance Manual (CPGM) on how FDA investigators are trained to conduct inspections of Institutional Review Boards (IRBs). The completion of this CPGM finalizes the recent updates to the FDA’s approach for inspecting key entities involved in the conduct and/or support of clinical research. This web seminar will review the FDA’s current focus during inspections and the factors driving these changes.

Learning Objectives

  • Review how new regulatory requirements are being incorporated into inspections
  • Discuss the new guidance and rules that support changes in inspection focus
  • Assess the FDA’s application of the guidance as reflected in regulatory communication
  • Examine steps for preparation of an inspection

Who Should Attend

This course is recommended for experienced:

  • Clinical Quality Assurance Professionals
  • Clinical Research Associates
  • Project Managers
  • Personnel involved in IRB assessment and/or selection, Clinical Investigators, Study Coordinators, IRB Members, IRB Professionals, Institutional Officials involved in oversight of clinical research, and GCP-Focused Regulatory Affairs Professionals working with IRBs that review, approve, and oversee clinical investigations regulated by the FDA

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 1.5 hours (0.15 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#: 0778-0000-12-066-L01-P. Released: 7/12. 

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. 


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

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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  

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

Use of Notes to File in Clinical Trial Essential Documentation 

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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)