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ISBT - EBA Symposium Tuesday 27 April 2004 The Netherlands Royal Academy of Sciences Kloveniersburgwal 29, Amsterdam, The Netherlands   Programme 08.30 - 09.15   Registration - Coffee/tea 09.15   Opening Hans-Erik Heier, ISBT President 09.30   Expectations for validation - Chair: Johan van der Does ISBT Guidelines for validation of automated systems in blood banking - risk assessment and responsibilities Charles Munk, Swiss Red Cross Regional Blood Transfusion Service, Vaud, Switzerland Relationship with suppliers - what are the expectations Mike Clark, National Blood Service, England Validation policy at the German Red Cross Blood Transfusion Service, West Wolfgang Steinke, GRC Blood Transfusion Service, West, Germany 10.45 - 11.15   Break 11.15   Information system validation - Chair: Charles Munk Maintaining the validation state - the needs of users Ad Saers, Sanquin Blood Supply Foundation, The Netherlands Maintaining the validation state - the challenge Wayne Bolton, Australian Red Cross Blood Services, Australia IT system validation - procedures at the Finnish Red Cross Blood Service Marjatta Hirvonen, FRC Blood Service, Finland 12.30 - 13.30   Lunch 13.30   Automated system validation - Chair: Wolfgang Böcker First time validation of an automated system - a simple way Charles Munk, Swiss Red Cross Regional Blood Transfusion Service, Vaud, Switzerland Maintenance of an automated system at the Irish Blood Transfusion Service Susan McDonnel, Irish Blood Transfusion Service, Ireland 14.20 - 14.45   Break 14.45   Regulatory views on validation - Chair: Jeroen de Wit PIC/S (Pharmaceutical Inspection Convention Scheme) requirements for validation Janos Imre, National Institute of Pharmacy, Hungary 15.15   Panel - Chair: Paul Strengers, ISBT Secretary General 15.45   Closure Jeroen de Wit, Sanquin Blood Supply Foundation, European Blood Alliance 16.00   Farewell reception