Sessions at Quality Management Systems for the BioPharma Cold Chain on Thursday 19th April

* Establishing a qualification master plan
o Design qualification and functional requirements
o Operational and performance qualification
* Packaging shipping configurations and distribution
* Temperature mapping
* Establishing worst case scenarios
o Shipping configuration and conditions
* Performing simulation studies
* Implementing the process with actual product shipment studies

* Implementation of the Quality System
* Deviations in the supply chain
o Temperature monitoring techniques
o Defect simulation
* How to access deviations
o Risk Assessment and root cause analysis
+ Product impact
o Risk control approaches
+ Corrective and Preventative Actions
o CAPA Effectiveness
+ Risk review, data collection and assessment of current validation state
+ Risk management strategies to prevent temperature excursions