Sharing best practices: quality risk management, change control, validation and qualification in blood establishments
The conference on “Sharing best practices: quality risk management, change control, validation and qualification in blood establishments” (Strasbourg, 17–19 October 2017) stemmed from a desire to share current practices on the implementation of key quality management elements, such as quality risk management, change control and validation/qualification in BEs, and how to apply them in the field. Thirty-six speakers from authorities, inspection bodies, blood establishments and suppliers provided 134 attendees from 34 different countries with information on the current regulatory requirements and presented their know-how and practical experience in the field of qualification, validation, change management and risk management. Discussions during the conference focused on clarifying these concepts, delineating their practical implementation and shedding light on the roles and responsibilities of the different stakeholders. These proceedings reproduce the presentations with the kind permission of the speakers and provide summaries of the sessions and recommendations ensuing from the presentations and discussions.
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