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Examining Revisions to the FDA ORA Compliance Program Guidance Manual September 2010

Sep 29, 2010
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Course Description


Clinical Investigator compliance has long been a key metric for assessing the credibility of data obtained from, and the protection of human participants involved in, clinical research. In an effort to increase uniformity in inspections and secure compliance, the FDA has recently reassessed and updated how its investigators inspect Clinical Investigators. This course will examine the new FDA/ORA Compliance Program Guidance Manual and highlight the recent changes and how they reflect the agency’s current focus on assessing the conduct of clinical trials.

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Learning Objectives

  • Examine the FDA’s revised approach to evaluating historic noncompliance issues, as well as new areas of concern
  • Describe how information on electronic records and signatures will be assessed during inspections and additional requirements for U.S. Investigators inspected by foreign health authorities
  • Explain how the Clinical Investigator’s responsibilities and interaction with other key clinical research team members will be evaluated

Who Should Attend

  • Clinical Quality Assurance Professionals
  • Clinical Research Associates
  • Project Managers
  • Clinical Investigators
  • Study Coordinators
  • Institutional Officials involved in oversight of clinical research
  • GCP -Focused Regulatory Affairs Professionals

Instructor 

Elizabeth Ronk Nelson, MPH

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Course Length Time

2 hours; 1:00 - 3:00 p.m. Eastern

Course Dates 

September 29, 2010                       

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!
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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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2012 Good Clinical Practice Question & Answer Guide Electronic Edition 

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CFR/ICH GCP Reference Guide 2012 (Perfect Bound) 

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