Sessions at Quality Management Systems for the BioPharma Cold Chain on Thursday 12th April

* Understanding global regulatory expectations (regulator, customer and supplier)
* Defining the distribution supply chain and critical control points
* Three pillars of an effective cold chain management process
o Quality Management System
o Transportation/storage controls and validation
o Risk management and mitigation

* Establishing a Quality Management System framework
o Organization and responsibility
o Training and communication
o Process and implementation plan
o Documentation requirements
* Integration of quality, customer and regulatory requirements
o Regulatory compliance
o Quality metrics
o System monitoring and improvement