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Understanding Cleanroom Manufacturing for Medical Devices
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Understanding Cleanroom Manufacturing for Medical Devices

25 November 2025 | Short Online Course

Original price was: £350.Current price is: £280.

(9 customer reviews)

1-day live online training | Have confidence in your cleanroom design, testing and microbiological monitoring with this 1-day course – Click Here to Download the Agenda

Register Early To Save

 

Enrol before 31 October to save 20% (November Course)

Discount has been applied to the price above. VAT, if applicable, will be added.

Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.

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

Download the Agenda

 

You can view the agenda by scrolling down on this page. If you would like to receive a PDF version with all the course information, please complete the form below.

 

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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

What is Included in a Short Live Online Course?

 

  • Direct access to an expert trainer through interactive and engaging sessions
  • Unlimited access to session recordings for 2 weeks after the course (live format)
  • One month of unlimited access to recordings and slides (on-demand format only)
  • Validated certificate of attendance, available to download or share on LinkedIn

Course Dates

 

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

25 November 2025

1-Day Live Online Training
Register at the top of the page.

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.

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.

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 online.
  • 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.

 

Frequently Asked Questions (FAQs)

Learn more about the course by toggling through the tabs below (Agenda, Trainer and Who Should Attend?)

 

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

25 November 2025 | 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).

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

9 reviews for

Understanding Cleanroom Manufacturing for Medical Devices

25 November 2025 | Short Online Course

  1. Educo Life Sciences –

    This is a new course – Reviews will be added after the first delivery!

  2. Innovia Medical (verified owner) –

    Very helpful informative trainer.

  3. Ambu (verified owner) –

    The teacher was very good at giving real-life examples of how to implement the course content

  4. 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.

  5. Medeco B.V. –

    To gain specific skills for my current job / role To gain specific skills for a future job / role

  6. 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!

  7. 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!

  8. Abbott –

    Thank you very much for the course! It was very well structured and provided a broad overview useful for praxis.

  9. Orthocell Ltd –

    I enjoyed the course. As I had just finished a full days work it was tiring

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