Validation of cleanrooms according to EN ISO 14644 series

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 EU MDR and UK MDR.

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 UK MDR/ EU 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

Prerequisites

Participants should have basic knowledge of microbiology, physics and quality management systems.

How will I learn?

MDSSPRO uses interactive teaching techniques, keeping the course varied and stimulating through exercises, working applications and case studies. Experienced and knowledgeable industry-leading tutors ensure individuals stay engaged throughout the course and that the learning objectives are met.

The course can be run online or onsite at company offices.

MDSSPRO’s online training course is powered through a Performant Software platform. Online tutors are available throughout the length of the course offering full support to course participants, answering questions, offering advice and explaining course material as required.

Price

We are providing online training course for £500 per person on our platform https://mdsspro.talentlms.com/index. The content is available for 3 months after registration.

A certificate is delivered after completion of the training.

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