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The 5th Annual Sterilisation for Medical Devices

Why attend 2012's Sterilisation for Medical Device conference?

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.

Notified body input, PLUS experienced consultants and industry feedback

Notified body input, PLUS experienced consultants and industry feedback

Jan Havel Sterilisation Product Specialist & Auditor TUV SUD

Caroline Murphy Assoc Director of QA (Sterilisation & Distribution) EMEA Teleflex Medical

Simon Redfern Microbiology Manager (Europe) Smiths Medical

Dan Vukelich Principal Attorney Association of Medical Device Reprocessors

 

     
  • Saleh Al Tayyar Ph.D, Vice Executive President for Medical Devices Sector, Saudi FDA, Saudi Arabia
  • Denys Durand-Viel, Medical Department Manager, TUV Rheinland, France
  • Jan Havel, Sterilisation Product Specialist, Auditor, TUV SUD Product Service, Germany
  • Arjan van Drongelen MSc, Senior Scientific Officer, Dutch Ministry of Health, Welfare & Sports, Netherlands
  • Ulla Christensen, Project Manager, Novo Nordisk AS, Denmark
  • Leisel Masson, Sr. Divisional Microbiologist, Stryker Orthopaedics, US
  • Kylie Fitzpatrick, Quality Engineer, Boston Scientific, Ireland
  • Caroline Murphy MSc, Assoc Director of QA (Sterilisation & Distribution) EMEA, Teleflex Medical, Ireland
  • Simon Redfern, Microbiology Manager Europe, Smiths Medical, UK
  • Beate Allgeier, QA - Sterility Assurance Specialist, Stryker, Germany
  • Sean Hanley, Corporate Sterilisation Steward, Boston Scientific, Ireland
  • Hans Hartmann, Managing Director, LEONI Studer Hard AG (a member of Synergy Health Group), Switzerland
  • Dan Vukelich, President, Association of Medical Device Reprocessors, US
  • Barry Parsons, Professor of Biochemistry, Faculty of Health, Leeds Metropolitan University, UK 
  • Henry Sibun, External Auditor/Independent Consultant, Henry Sibun Associates Ltd., UK
  • Celine Malo, International Regulatory Affairs Consultant, Meditec Consulting GmbH, Switzerland
  • Michael Maier, Senior Partner, Medidee sarl - Medical Device Experts, Switzerland
  • Philip Schneider, Senior Consultant, LexaMed, USA
  • Neil O'Flaherty, Esq., Principal, Olsson Frank Weeda Terman Matz PC, US

Workshops & Evening Seminar

   
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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(updated 21 May 2013)

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