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Adequate Sponsor Monitoring Systems in Anticipation of FDA Sponsor GCP Inspections January 2012

Jan 13, 2012
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Course Description 

In the current regulatory climate, sponsors should anticipate more FDA sponsor GCP inspections and information requests regarding monitoring practices. Many monitoring systems lack components that ensure proper management of the research site without relying on the “star performer.” Monitoring systems should include specific components to ensure control of investigational product, data integrity, oversight of vendors, as well as other areas. The components of a quality monitoring system will be presented so that participants can assess their current practices for identifying gaps and risks, particularly in relation to preparing for regulatory inspections of sponsor monitoring programs.

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Learning Objectives 

  • Discuss BIMO sponsor CRO and monitors program
  • Identify components of a sponsor monitoring system: beyond SOPs
  • Distinguish each component’s suggested elements
  • Define adequate oversight of non-employee performers
  • Identify other measures to ensure quality monitoring
  • Evaluate gaps in monitoring systems

Who Should Attend 

  • Sponsor Senior Management
  • Project Managers
  • CRA Managers
  • QA/Compliance
  • CRAs

Instructor 

Elizabeth Ronk Nelson, M.P.H.

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Course Length Time 

2 hours; 2:00 - 4:00 p.m. Eastern

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

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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)