Risk management in Medical Devices and Bio Products - Applying ISO 14971:2000

Date : Thursday 25.11.04

Details : BioMedIreland* is delighted to announce the first in a series of networking events in Quality Assurance and Regulatory Affairs. This event will give Directors, Management Teams, Product Design Managers, Engineers, Process Owners, Quality Assurance and Regulatory personnel a strong foundation for those new to the international risk management standard and it provides a concise refresher to people experienced in the regulatory field. It will enable all attendees to understand how the standard helps in the move toward global harmonisation and provide some guidelines in its use.

Dr Peter Donnelly – CEO BioBusinessNI will chair this event introducing: The ISO 14971:2000 standard; Subjective and Objective view(s); Integration into your Quality System; A Practical Example; Tools and Techniques – Management Actions; and a plenary session with the panel to answer questions arising from the attendees.

Speakers:

EurIng Neil R. Armstrong B.Sc. C.Eng. M.I.E.E. M.B.I.R.A. R.A.C. MD MeddiQuest Limited, Chairman Medical Devices Quality Group – Institute of Quality Assurance

Mark Boult, Principal Consultant – Den Norske Veritas

Registration Details

Time : 09:30 for 10:00 start
Date : Thursday, 25th November 2004
Venue : Crowne Plaza Hotel
Dublin Airport
Fee : €95.00 euro pp

Continental breakfast and lunch will be served.

PLEASE NOTE: There are a limited number of places available for this workshop, bookings will only be taken on-line and an invoice will be sent to you after the event.

To book places at this workshop please use the link below:

www.ibec.ie/0/BioMedIreland

* BioMedIreland is an all-island network, established by IMDA, IBIA, BioBusiness NI and InterTradeIreland to facilitate & enhance the competitive positioning and innovation capabilities of the health technology and biotechnology sectors on the island of Ireland.


Location : Crowne Plaza Hotel , Dublin Airport

Times:
09:30- 10:00

Cost:
€95 euro

Contact:
Northern Ireland:

Brian Anderson

Tel: +44 28 9073 7949

Mobile: +44 7730 811899

Email: brian@biobusinessni.org



Republic of Ireland

Mark Cooney

Tel: +353 1 6051593

Mobile: +353 87 2197614

Email: mark.cooney@ibec.ie



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