A Two-Day Training Course providing an understanding of Microbiology for the Non-Microbiologist working in the Medical Devices Industry and Notified Bodies
To provide those involved in QA, Production and conformity assessment of medical devices with an understanding of the controls necessary in the manufacture of microbiologically clean and sterile devices, especially where demonstration of compliance with the Medical Devices Directives is the ultimate goal. The course is designed specifically for those with no microbiological background, although it could also be of benefit to newly graduated microbiologists entering the medical devices field for the first time.
Attending the course will enable delegates to:
WILL BURTON is a Pharmacist and Qualified Person. Prior to becoming RSQA's Managing Director he was the Business Manager of the Department of Health's Manufacturers Registration Scheme. He is an IRCA Registered International Lead Assessor with 13 years of auditing experience covering all types of medical device manufacture worldwide. Lately he was involved in recruiting and training assessors for UK and European Notified Bodies. His work for RSQA has included medical device and pharmaceutical consultancy, design dossier compilation and review, 3rd party and internal assessments. He is a well-known speaker at public seminars and courses.
STEVE ELLIS is a Microbiologist and Qualified Person and an RSQA Senior Consultant. Steve joined the Department of Health MRS Section in 1992 and became an IRCA Registered International Lead Assessor in 1995. Steve later transferred to the European & Regulatory Affairs Group where, as the MDA's Senior Auditor he played a key role in the designation and surveillance of UK Notified Bodies. While with the MDA he provided regulatory advice on microbiological issues to a large number of manufacturers.
We engage other authoritative sources of expertise according to the requirements of the training group. In the past this has included Dr Roz Baird of the University of Bath.
This will include a historical account of the development of microbiology, involving the work of Pasteur and Koch amongst others and with special reference to microscopy and cultural methods as tools. The account will also deal with marker organisms as a means to recognise sources of contamination, pyrogens and endotoxins.
Providing an account of the treatment of water, plant cleaning methods, raw materials as contamination sources (bioburden) and aseptic processing. The module will also discuss how bioburden and pyrogens/endotoxins may be reduced to acceptable levels and controlled during manufacture.
This module will include discussions on disinfection of medical devices and the manufacturing environment and the use of Dry Heat, Steam, Ethylene Oxide and Radiation for device sterilization. A brief overview of inactivation kinetics will be presented and issues related to sterility testing will also be discussed - in particular the cases for and against. Reference will be made to European sterilization Standards ISO 11135, ISO 11137 and ISO 17665, and how these Standards relate to EN 556 - the requirements to be fulfilled in order to label a device "Sterile". Consideration will also be given to some less common sterilization processes, e.g. Hydrogen Peroxide/Gas Plasma and Intense White Light.
To include consideration of the Standards currently available, e.g. ISO 14644, controlled area commissioning, routine control and monitoring and personnel issues.
Will include consideration of the microbiological aspects of ISO 13485 and associated guidance documents. The module will explain how the assessors audit systems for microbiological compliance and draw attention to key areas of particular importance.
The course has included demonstrations of microbial growth and morphology, contaminants isolated from common sources, sampling techniques and an overview of common identification systems.
For further information please email us or call us on +44 (0) 207 936 9412.
Russell Square Quality Associates Ltd.