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.

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
• Interactive and engaging sessions
• Access to the Educo Life Sciences Training Portal
• Unlimited access to the recordings for 2 weeks after the session

Course Dates

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

5 December 2024

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

19 March 2025

1-Day Live Online Training
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17 July 2025

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

9 December 2025

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

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)

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