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9 reviews for
Understanding Cleanroom Manufacturing for Medical Devices
7 May 2026 | Short Online Course
£280 £350Price range: £280 through £350
Have confidence in your cleanroom design, testing and microbiological monitoring with this 1-day course
Learn more about the course by toggling through the tabs below.
Course Overview
Many medical devices and IVDs must be manufactured in cleanrooms to ensure they are safe for the patient/end user. A cleanroom is designed to control the airborne particles and microorganisms that could cause contamination. The type of cleanroom and regulatory requirements to adhere to is dependent on the product and level of risk to the patient.
This short live online course on cleanroom manufacturing will provide you with an in-depth insight into cleanroom design, classification, testing and microbiological monitoring. The 1-day course will improve your knowledge and application of ISO 14644 parts 1-5 and EN 17141:2020. You will also review ISO 14644 parts 7-10, ISO 14698 parts 1-2 and ISO 11737-1 as well as EU GMP requirements for pharmaceutical and biotech industries. The main objective of the course is to provide an overview of cleanroom technology and control rather than an in-depth review of aseptic processing which is in itself a detailed topic. Once completed you will be confident in cleanroom manufacturing for your device product(s). Learn more about how we deliver live online training
Key Learning Objectives
- Fully understand cleanroom design and systems available
- Review best practice for controlling people and materials in a cleanroom environment
- Discover the cleanroom classifications and what is applicable to your product
- Analysis cleanroom testing requirements
- Examine microbiological monitoring
Who Should Attend?
This short live online course is suitable for professionals involved in cleanroom manufacturing within medical devices, IVDs and pharmaceuticals and includes:
- Quality assurance
- Regulatory affairs
- Production managers
- Engineers
- Supply chain managers
- Internal auditors
- Packaging and environmental engineering
Course Information
Course Information
- 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
7 May 2026 | 20 October 2026
1-Day Live Online Training
Register at the top of the page.
Session 1
120 mins | 10:00 AM UK
The course will review the requirements of ISO 14644 parts 1-5 and EN 17141:2020 in detail. This course will also touch upon ISO 14644 parts 7-10, ISO 14698 parts 1-2 and ISO 11737-1 as well as EU GMP requirements for pharmaceutical and biotech industries. However this course is intended more as an overview of cleanroom technology and control rather than an in-depth review of aseptic processing which is in itself a detailed topic
Cleanroom design and operation
- Airflow principles and systems
- Other construction considerations
- Control of people and materials
- Cleaning and monitoring
Cleanroom classification and testing
- Required classification(s)
- Non-viable particle testing
- Other testing / validation requirements
Session 2
120 mins | 1:00 PM UK
This course will also touch upon ISO 14644 parts 7-10, ISO 14698 parts 1-2 and ISO 11737-1 as well as EU GMP requirements for pharmaceutical and biotech industries. However this course is intended more as an overview of cleanroom technology and control rather than an in-depth review of aseptic processing which is in itself a detailed topic
Microbiological monitoring
- Monitoring plan and methods
- Setting warning and action levels
- Investigation and corrective action
Additional considerations
- Chemical contamination
- Aseptic processing
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).
Format, Dates & Times
Find out when this course is running so you can plan your training. Scroll down to view the full agenda.
7 May 2026
1-Day Live Online Training
Register at the top of the page.
20 October 2026
1-Day Live Online Training
Register at the top of the page.
On-Demand Access
Can’t wait for the next course date?
Get instant access to the training materials by selecting ‘On-Demand’ from the drop-down menu above. Start learning at your convenience. You’ll also be added to the next live session, giving you the opportunity to attend and interact directly with the trainer if you wish.
Course Times
For live online delivery, the course starts at 10:00 AM (UK time) and finishes at 3:00 PM (UK time).
Group Discount
If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.
For a quote, complete our contact form by following the link. Get in touch.
Customised Team Training
We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.
For more information, complete our contact form by following the link. Get in touch.
What is Included?
Certification
Download your official Educo Life Sciences Certificate of Attendance to showcase your achievement and professional development.
Access to Recordings for 2 Weeks
Enjoy unlimited access to all session recordings for up to two weeks after the final session — perfect for revision or catching up.
Learner Reference Guide
Attendees receive an overview packed with key concepts, examples, and references from your training to support you long after the course concludes.
On-Demand or Live Online
This course is delivered live or you can access on-demand materials immediately to begin learning straight away.
4 Hours of Learning
This course includes a total of 4 hours of learning.
Expert Trainer
Engage directly with leading trainers who bring real-world experience and insider knowledge to every session.
Additional Course Information
Free Online Module
Free Online Module
- Some of our courses include a free to attend module 1. Please check above to see if this applies to this course.
- If applicable, module 1 is free to attend and delivered online at a date 3 to 8 weeks before the full course start date.
- To register for module 1, please submit your details in the form located above.
- Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.
Full Course Information and Pricing
Full Course Information and Pricing
- To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
- There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
- The full training course is delivered either online or in a classroom. Please check which course format you have booked.
- For hybrid training – In the event we do not have enough people on one of the options we will contact you to discuss switching.
- For live online courses – The dates and times of modules/sessions are subject to change.
- For live online courses – The module/session durations are approximate.
On-Demand Information and Pricing
On-Demand Information
- Most courses are available on-demand. If you select this option you will be able to begin training instantly.
- You will gain access to a previous live online session, slides and learner reference guide.
- You will also be added to the next live session, giving you the opportunity to attend and interact directly with the trainer if you wish.
- Depending on the course length you will have access to the on-demand materials for 1 to 3 months.
9 reviews for Understanding Cleanroom Manufacturing for Medical Devices
7 May 2026 | Short Online Course
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Educo Life Sciences –
This is a new course – Reviews will be added after the first delivery!
Innovia Medical (verified owner) –
Very helpful informative trainer.
Ambu (verified owner) –
The teacher was very good at giving real-life examples of how to implement the course content
Insight Medical Products (verified owner) –
The course hosted by Annette, was at a great pace and factful. Annette explained everything thoroughly and answered questions when asked. One of the best courses I have been on to date.
Medeco B.V. –
To gain specific skills for my current job / role To gain specific skills for a future job / role
Orthocell –
Very informative session, delivered in a succinct and engaging manner. I highly recommend this course to those with various levels of experience in the industry. Annette was fantastic!
UAB Intersurgical –
Great course, I’m not new in the field and came with specific complex questions and I get all answers from experienced speaker, so can apply this knowledge directly in our company for its benefits, very practically useful!
Abbott –
Thank you very much for the course! It was very well structured and provided a broad overview useful for praxis.
Orthocell Ltd –
I enjoyed the course. As I had just finished a full days work it was tiring