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.