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9 reviews for
Understanding Cleanroom Manufacturing for Medical Devices
20 March 2025 | Short Online Course
£280.00 – £350.00
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
Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.
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
Session 1
20 March 2025
17 July 2025
9 December 2025
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
20 March 2025
17 July 2025
9 December 2025
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
20 March 2025 | 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