Events

MedTech Workshop: Awareness Training on Sterilisation of Medical Devices

Date: 31 Aug 2010 - 01 Sep 2010

Venue: SIMTech Auditorium, Tower Block, Level 3

Introduction 

This introductory workshop is specifically designed for participants to gain a clear understanding of the science of sterilisation processes in the medical device industry. The process of sterilising a medical device prior to bringing it to market is widely recognised as a critical process in the medical device industry. Common industrial level methods of sterilisation include controlled exposure of the devices to irradiation or gaseous ethylene oxide (EO). In principle, any method that is used for sterilisation is expected to provide a high level of assurance that the end product is sterile. This can be achieved by ensuring that the process used is developed, validated and controlled according to the requirements set forth in standards such as ISO 11137 (irradiation) and ISO 11135 (EO). Participants of this programme will be provided with a structural introduction to the concept of sterilisation in the medical device industry and requirements of these two standards. Particular attention shall be paid to how these requirements ensure that devices marketed are safe and effective from a sterility perspective. Discussions will also focus on the regulatory and quality assurance processes which manufacturers worldwide are required to implement as part of their efforts to control and validate sterilisation processes. This workshop is co-organised by TÜV SÜD PSB (http:/www.tuv-sud-psb.sg) and SIMTech (www.SIMTech.a-star.edu.sg).

About the Speaker
Dr Vincent Lam is the Manager of Medical Health Services in TÜV SÜD PSB Malaysia. In this capacity, he oversees the auditing and compliance activities of medical device manufacturers who are certified by TÜV SÜD Product Service. Dr Lam is trained as a Microbiologist and has over 17 years of experience in the medical device industry, participating primarily in quality assurance and regulatory affairs where he oversees the compliance positions of medical manufacturers. As a Notified Body and lead auditor, he performs audits extensively according to regulations such as the Medical Device Directive of the European Union, the Canadian and Japanese Medical Devices Regulations and ISO 13485:2003. His primary area of expertise is in the regulatory requirements of medical devices. Dr Vincent Lam is a member of the Chartered Institute of Biology of the United Kingdom and a member of the Working Group 4 of the Asian Harmonisation Working Party, whose principal aim is to establish common positions for the harmonisation of medical devices regulations in Asia. He also specialises in risk analysis and assessment, industrial sterilisation of medical devices, biological safety of materials and packaging.

Programme

Day 1

8.30am

Registration

9.00am

Introduction of Speaker

9.15am

Sterilisation and Sterility in the medical device industry

10.30am

Tea Break

11.00am

Irradiation Sterilisation of Medical Devices I: The Microbiological Perspective

12.30pm

Lunch

1.30pm

Irradiation Sterilisation of Medical Devices II: The Physical Perspective

3.30pm

Tea Break

3.45pm

Continue with Irradiation Sterlisation

4.45pm

Q&A

5.30pm

End of Session

Day 2

9.00am

Presentation and Discussion on Ethylene Oxide as a Sterilisation Agent

10.30am

Tea Break

11.00am

Validation of an EO Sterilisation Process

12.30pm

Lunch

1.30pm

Process Control in EO Sterilisation

3.30pm

TeaBreak

3.45pm

Process Control in EO Sterilisation

4.45pm

Q&A

5.30pm

End of Session

Who Should Attend
Supervisors, Executives and Managers representing the departments of :
-  Quality Assurance
-  Production
- Logistics and Warehouse
- Plant Engineering

- Industry participants who need to gain relevant and practical information in fulfilling regulatory requirements in the sterilisation of medical devices in compliance with the harmonised standards.
 
Registration Fees: S$535.00 (inclusive of 7% GST)per participant.

MedTech Manufacturing Consortium Member is entitled to 2 complimentary seats.
SIMTech SMS member will be entitled to a 20% discount (S$428.00 per participant). 
Pre-registration for the workshop is required. To reserve a place, please register online.

All cheques and bank drafts must be made payable to "Singapore Institute of Manufacturing Technology', crossed and marked 'A/C payee only'. The workshop title should be written on the back of the cheque.

GST Registration No : M9-0000888-J

Contact Us
For technical enquiries:
Mr Yeo Joo Chuan, Email: jcyeo@SIMTech.a-star.edu.sg; Tel: 6793 8980

For general enquiries:
Alice Koh, Email: kohth@scei.a-star.edu.sg; Tel: 6793 8249