Tissue establishments implement a quality management system (QMS) to ensure that tissues and cells consistently comply with technical and legal requirements; this QMS must cover all aspects of the activities undertaken by the tissue establishment. During the last decade, many sector developments have led to continuous changes in the organisation of tissue establishments and in their approaches to ensuring safety and quality. The concept of quality management (QM) has also greatly evolved within this field and, consequently, tissue establishments have had to continually adapt to new requirements.
The EDQM/Council of Europe plays a central role in the field of tissues and cells for human application by facilitating the exchange of knowledge and promoting the harmonisation of practices throughout Europe. It captures changes in the field in regular updates to the Guide to the quality and safety of tissues and cells for human application, which aims to provide sound information and guidance to optimise the quality and minimise the risks of these complex procedures. The recently published 4th edition includes Good Practice Guidelines (GPGs) for tissue establishments, which consolidate the guidance that is already defined in existing legislation and scientific guidelines.
The aim of this training course was to provide tissue establishments in Europe with the tools required for the successful implementation of a QMS, from identification of a potential donor through processing and storage of the tissues or cells to the final preparation for application to the patient.
The course covered the fundamental aspects of quality management in the field of tissues and cells and provides guidance on how to ensure its implementation.
The main topics covered were:
- Validation and qualification
- Good Practice Guidelines
- Personnel
- Internal audits
- Biovigilance
- Risk assessment tools
- Documentation
- Standard operating procedures (SOPs)
- Microbiological testing
- Environmental monitoring
The course has been prepared by top European experts in the field and it provided participants the opportunity to build knowledge and competencies by combining online weekly lectures (pre-recorded for participants to watch at their own pace) and active participation in online live workshops and debates.
Target audience
This course is of interest to healthcare professionals working in organisations that handles tissues and cells for human application in a role as a Quality Manager and Responsible Person.
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