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
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.