Validation of Cleanroom

Cleanroom validation training

This course - Validation of Cleanroom - is designed to provide participants with an understanding of the EN ISO 14644 series requirements for sterile medical devices and compliance with MDR .

This 1 day training course provides an in depth knowledge of the EN ISO 14644-1 to -5 requirements as well as attendant study cases.  Get in touch with Medical Device Software & Sterilization Professionals in Lee-on-the-Solent in Hampshire should you wish to take the course.  We offer access worldwide.

Learning objectives / course outcomes

On completion of this training, participants will be able to:

  • Identify the links between 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- Setting up a cleanroom
  • V- Validation of the cleanroom
  • VI- Monitoring of the cleanroom
  • VII- Maintenance of the cleanroom

Prerequisites

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

How will I learn?

MDSSPRO use interactive learning techniques so as to keep the course.  Also incorporated are applications and study cases.  Our tutors are some of the best in the area and will make sure your learning needs are met. Choose between online or in-company courses, either can tailored to your business's needs.

Price

The course is £450 per person. We also offer this training at a special price for students, for more details contact us at admin@mdsspro.com. 

On site training can be tailored to your need needs. For more details, contact admin@mdsspro.com.
If you have any queries about our Validation of Cleanroom course, please email
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