Venue: EDQM Premises, 7 allée Kastner, 67081 Strasbourg, France
Working language: English
This event is fully booked.
Deadline for registration: 31 May 2017
Background information and objectives
Blood transfusion carries intrinsic risks. The implementation of a Quality Management System (QMS) in Blood Establishments (BEs) is thus of the utmost importance to manage these risks – ensuring the efficacy, safety and quality of blood components.
The complexity of current quality requirements has led to difficulties for European BEs trying to implement integrated QMSs, especially in the introduction of quality elements such as quality risk management, change management and validation/qualification (three concepts which are intrinsically linked) and their sustainability.
It has been recognised during auditing and inspection schemes that requirements for these elements are subject to interpretation, leading to differing expectations between blood establishments, regulating bodies and inspectors as regards their practical implementation.
While these elements are clearly required by the EU Blood Directives, the Council of Europe Guide to the Preparation, Use and Quality Assurance of blood components and the recently developed Good Practice Guidelines (GPG), there is currently very little data – and especially little guidance – on “how” these elements have to be followed and "to what extent".
It is worth mentioning that, as from 15 February 2018, the implementation of these elements will become mandatory with the transposition of Commission Directive (EU) 2016/1214 into the national legislation of the European Economic Area (EEA) Member States.
Last but not least, suppliers’ and users’ duties and responsibilities relating to qualification and/or validation, and especially to acceptance testing, remain currently a grey area. Prompting discussion between blood establishments and suppliers would therefore help to clarify roles and respective expectations.
During this conference, speakers from authorities, inspection bodies, blood establishments and suppliers will provide you with information about the current regulatory requirements and present their knowledge and practical experience in the field of qualification, validation, change management and risk management.
In addition, discussions will aim at clarifying these concepts, delineating their practical implementation and clarifying responsibilities of the different stakeholders.
This event ultimately aims at drafting recommendations to provide the basis for an update of current regulatory standards.
A poster session on the topics covered by the conference will be organised during the conference. Call for submission of Poster abstracts is open until 30 April 2017. More information on the right column.
Who should attend?
This conference is designed for
- Blood Establishments personnel experienced in change control, quality risk management, validation and qualification
- National, international authorities and inspectors
- Blood establishment suppliers
- Manufacturers of Plasma Derived Medicinal Products
- Risk Management
- Change Control
- Validation and Qualification
- Good Practice Guidelines (GPG) for Blood Establishments
- Best Practices in Quality Management for Blood establishments