FHI360

Background

Support the CDC clinical trials for an Ebola vaccine in Sierra Leone through one primary depot, two sub-depots, and approximately seven trial sites.The vaccine is stored at and shipped from the main depot at minus 80°C.  Within 24 hours of administration, the vaccine is thawed, diluted, and filled into a syringe for dosing at the trial site between 2°C to 8°C.

Objectives

  • Manage operations to maintain proper vaccine temperature.
  • Address technical and operational problems they occur.
  • Identify any potential issues and recommend possible remediation.

Results

  • Executed and documented training plan on all appropriate SOPs and policies.
  • Comprehensive risk assessment in a Risk Management report in the quality management system.
  • Weekly metrics on cold chain – chain of custody, temperature control and on-time delivery.

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