Course Description

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

 

Intended audience

• Regulatory, quality assurance managers and personnel

• Design and development managers and personnel

• Quality control personnel

 

Content of the course

I- Introduction

II- Classification of the cleanroom

III- Control of contamination

IV- Metrology

V- Setting up a cleanroom

VI- Validation of the cleanroom

VII- Monitoring of the cleanroom

VIII- Maintenance of the cleanroom

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Prerequisites

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.

 

Price

 We are providing online training course for £450 per person. We also offer this training at a special price for student, for more details contact us at admin@mdsspro.com. 

 

On site training is tailored by on your needs. For more details contact admin@mdsspro.com