Informa Life Sciences' annual conference on Sterilisation for Medical Devices brings together leading sterilisation and quality assurance experts from some of the leading industries and Notified Bodies. We pride ourselves on bringing you some of the best speakers in the field with the practical information to make your sterilisation processes highly efficient efficient.
This year, we bring to you practical case studies from some of the leading industries in the field. We also have 2 Notified Bodies giving you advice on understanding and complying with NB requirements and how to satisfy the sterilisation ISO standards. We also bring you valuable insight from the Saudi FDA on single use devices and the consequences of reuse.
This conference offers expert speakers, key information on which devices should be sterilised in which way and why, as well as how to be compliant, validation of your sterilisation process and advice on outsourcing sterilisation. Methods covered include ethylene oxide sterilisation, hydrogen peroxide/gas plasma sterilisation and radiation sterilisation. Also explore the importance of bioburden control and take a look at the capability of emerging markets for sterilisation.
Evening seminar - WEDNESDAY 23 MAY 2012
Harmonisation of NBs: Where are we?
-Exploring the current state of affairs for sterilisation of medical devices: the degree of consistency
-Challenges to be overcome and methods of achieving harmonisation for sterilisation of medical devices
-Examining the degree of harmonisation relating to cleaning process validation before terminal sterilisation of medical devices
-Understanding the degree of harmonisation on reusable devices between the FDA and Europe
-Future implications for harmonisation for sterilisation of medical devices
-Impact of the new regulation covering medical devices on the harmonisation of practices of Notified Bodies
Led by:
Denys Durand-Viel, Medical Dept. Manager, TUV Rheinland, France
Anwen Evans, Medical Regulatory Services Services Specialist, UL, UK
Saleh Al Tayyar, Vice Executive President for Medical Devices Sector, Saudi FDA
Michael Maier, Senior Partner, Medidee sarl - Medical Device Experts, Switzerland
Henry Sibun, External Auditor/Independent Consultant, Henry Sibun Associates Ltd., UK
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