Discount has been applied to the price above. VAT, if applicable, will be added.
Course Overview
Many medical devices must be sterilised to ensure they are safe for the patient. One of the most popular methods to sterilise a device is using ethylene oxide. Manufacturers using Ethylene Oxide Sterilisation (EOS) on their devices need to comply with international regulations and standards such as ISO 11135:2014, AAMI TIR28:2016 and ISO 10993-7:2008+AMD1:2019.
This short live online course will provide you an in-depth insight into EOS process, validation and monitoring. You will examine important standards ISO 11135:2014, AAMI TIR28:2016, ISO 10993-7:2008+AMD1:2019 that you must comply with when using EO as a sterilisation method. Once completed, you will have the knowledge and confidence to oversee of ethylene oxide sterilisation for your products. Learn more about how we deliver live online training
Key Learning Objectives
Examine the relevant standards for ethylene oxide sterilisation so your products are compliant
Fully understand the fundamentals of EOS such as process stages and critical parameters
Learn to perform various qualification steps to ensure your EOS process is fully validated
Examine how to monitor and control products to ensure they
Discover best practice for ethylene oxide residual control and testing
What is Included?
Direct access to an expert trainer
Interactive and engaging sessions
Access to the Educo Life Sciences Training Portal
Unlimited access to the recordings for 2 weeks after the session
Download the Agenda
You can view the agenda below or if you would like to receive a pdf version with all the course information, please complete the form below.
Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)
The course begins at the time stated at the top of the page
The course is broken up into modules outlined below
There will be breaks between modules
Session 1
13 July 2023 | 23 November 2023 | 120 mins | 10:00 AM UK
Throughout the course you will examine in-depth the requirements of ISO 11135:2014, AAMI TIR28:2016 and ISO 10993-7:2008+AMD1:2019. You will also touch upon ISO 11138 parts 1,2 & 7 and ISO 11737 parts 1 & 2.
Ethylene oxide sterilisation principles
Microbiocidal principles of ETO
ETO sterilisation process stages and critical parameters
Product characteristics affecting / affected by ETO
Validation of ethylene oxide sterilisation
Installation and operational qualification (IQ & OQ)
Microbiological performance qualification (MPQ)
Physical performance qualification (PPQ)
Product adoption into existing validations
Session 2
13 July 2023 | 23 November 2023 | 120 mins | 1:00 PM UK
Throughout the course you will examine in-depth the requirements of ISO 11135:2014, AAMI TIR28:2016 and ISO 10993-7:2008+AMD1:2019. You will also touch upon ISO 11138 parts 1,2 & 7 and ISO 11737 parts 1 & 2.
Routine monitoring and control
Product release from sterilisation
Assessment of change and revalidation
Bioburden monitoring
Ethylene oxide residual control and testing
Establishing limits
Testing process and considerations
Product release considerations
Jack Walters academic and industry research background is well suited to sterilisation and the associated technologies, having covered material science and engineering through to microbiology and toxicology. He was formally a member of BSI, CEN and ISO committees for sterilisation of healthcare products, as well as a subject matter expert on disinfection, packaging and sterilisation at a leading notified body. For the past number of years however he has focussed on provision of auditing, training and consultancy services via his own company founded in 2017 and selected partners, and remains an active member of a number of committees such as at the Institute of Decontamination Sciences as a member of the education committee.
Annette Callaghan A quality management professional, chartered biologist and member of the Royal Society of Biology, with over 35 years’ experience in the medical device, pharmaceutical, biotechnology and food industries. Extensive knowledge of quality and environmental management systems, internal and third-party auditing and personnel training. Eligible to act as a Qualified Person as defined in Directive 2001/83/EC, as amended (previously 75/319 et al.) since 1993. A Qualified Notified Body Lead Auditor since 2002 (IRCA ref: 1182641).
This short live online course is suitable for professionals involved with ethylene oxide sterilisation and includes:
Quality assurance
Regulatory affairs
Production managers
Engineers
Supply chain managers
Internal auditors
Packaging and environmental engineering
e-learning options
Want to train your team, department or whole organisation? This course can be developed into on-demand e-learning and hosted by Educo Life Sciences or on your own LMS platform.
We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.
For more information you can email us at [email protected] or call +44 (0) 203 111 7357.
Complete our contact form by following the link. Get in touch.
*
• This course is delivered online
• For live online courses, module durations are approximate
• You will have full access to the training portal and the recordings for 2 weeks after the training
