Presented by
Management Forum
Sterile devices are free of viable microorganisms and sterilization is one of the key processes in the production of sterile medical devices. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization is important and expected when demonstrating conformity with the regulations. This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them.
17-18 October 2024
+ 3-4 February 2025, 5-6 June 2025, 16-17 October 2025 »
from £1099
Sterile devices are free of viable microorganisms and sterilization is one of the key processes in the production of sterile medical devices. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization is important and expected when demonstrating conformity with the regulations.
These requirements have been supported by a portfolio of standards on:
This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them.
Please note that delegates will require access to copies of ISO 11135 and ISO 11137-1 in order to take part in the exercises. If you do not already have access to these through your organisation, please see below the ways to acquire them:
ISO 11135 - https://www.iso.org/standard/56137.html
ISO 11137-1 - https://www.iso.org/standard/33952.html and amendment at https://www.iso.org/standard/72106.html
These standards are also available from national standards organizations such as BSI, DIN, AFNOR, AAMI, NSAI, etc.
This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.
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).
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
17-18 October 2024
Live online
09:30-17:30 UK (London) (UTC+01)
10:30-18:30 Paris (UTC+02)
04:30-12:30 New York (UTC-04)
Timings may be different for each day
Course code 14185
Not ready to book yet?
for 7 days, no obligation
3-4 February 2025
Live online
09:30-17:30 UK (London) (UTC+00)
10:30-18:30 Paris (UTC+01)
04:30-12:30 New York (UTC-05)
Timings may be different for each day
Course code 14477
Until 30 Dec
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for 7 days, no obligation
5-6 June 2025
Live online
09:30-17:30 UK (London) (UTC+01)
10:30-18:30 Paris (UTC+02)
04:30-12:30 New York (UTC-04)
Timings may be different for each day
Course code 14730
Until 01 May
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for 7 days, no obligation
16-17 October 2025
Live online
09:30-17:30 UK (London) (UTC+01)
10:30-18:30 Paris (UTC+02)
04:30-12:30 New York (UTC-04)
Timings may be different for each day
Course code 15022
Until 11 Sep
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for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.
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Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: