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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
What is Included?
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
Download the Agenda
You can view the agenda below or if you would like to receive a pdf version with all the course information, please complete the form below.
Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)
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 July 2023 | 30 November 2023 | 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 July 2023 | 30 November 2023 | 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
e-learning options
Want to train your team, department or whole organisation? This course can be developed into on-demand e-learning and hosted by Educo Life Sciences or on your own LMS platform.
We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.
For more information you can email us at [email protected] or call +44 (0) 203 111 7357.
Complete our contact form by following the link. Get in touch.
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• This course is delivered online
• For live online courses, module durations are approximate
• You will have full access to the training portal and the recordings for 2 weeks after the training
