Validation of cleanrooms according to EN ISO 14644 series
This course is designed to provide participants with understanding of the EN ISO 14644 series requirements for sterile medical devices and compliance with MDR and MDD.
This 1 day training provides an in depth knowledge of the EN ISO 14644-1 to -5 requirements and study cases.
Learning objectives / course outcomes
On completion of this training, participants will be able to :
Identify the links between MDD/ MDR and ISO 14644 series
Explain terms and definitions
Explain how the requirements ensure a low bioburden
Define the cleanroom requirements
Identify the methodology used for monitoring
Define the key information of the validation of the cleanroom
Regulatory, quality assurance managers and personnel
Design and development managers and personnel
Quality control personnel
Content of the course
II- Classification of the cleanroom
III- Control of contamination
V- Setting up a cleanroom
VI- Validation of the cleanroom
VII- Monitoring of the cleanroom
VIII- Maintenance of the cleanroom
Participants should have basic knowledge of microbiology, physics and quality management systems.
How will I learn?
We use interactive learning techniques, keeping the course varied and with applications and study case. Our tutors are the best and will make sure your learning needs are met. Choose between online or in-company courses tailored to your business.
We are providing online training course for £450 per person
On site training is tailored by on your needs. For more details contact