Assess the controlled temperature (passive) shipper qualification processes. Compared to best industry practices and regulatory expectations, a recommended mitigation list was created to close the identified gaps. Implement recommendations and provide support and program management for the qualification of passive shippers.


  • Assessment to identify gaps and recommendations for improvement.
  • Update policy and procedures to meet all approved recommendations.
  • Support to leverage existing solutions and new shipper design.


  • Revised work instructions and updated documentation to ensure consistency and compliance.
  • Updated passive thermal packaging systems management and provided BLA submission support.
  • Created review and approval matrix and managed program activities with project teams.

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