Quality Assurance of a Cleanroom


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All our courses continue to evolve as standards and best practice change, and as we get feeedback from previous delegates. A general outline of the curriculum for the day wil include….

  • Cleanroom Introduction
  • Cleanroom Fundamentals
  • Validation Testing to ISO 14644-3:2019
  • Monitoring Plan for Continued Compliance
  • Environmental Monitoring & Investigation
  • Change Control
  • Auditing
  • Competency
  • Q&A

This will be an in-depth training course with an “open book” style exam.  Greater than 90% must be achieved to be awarded a Pass Certificate.  Any delegate not sitting the exam or not meeting the required standard will be awarded a Certificate of Attendance.


Maintaining a cleanroom to the relevant standards is often controlled by Quality assurance personnel, who may have limited  understanding of the standards applied to the design of the facility, and the practicality of building controls parameters such as HVAC, drains, pressure differentials people movement, particle monitoring etc. This course will not only give a fundamental background on the relevant standards in relation to cleanrooms and the expected contamination and microbial limits surrounding these, but will also provide an insight into the correct  Corrective and Preventive Actions (CAPA) needed to address issues as they arise. Participants will have the opportunity to raise concerns or questions regarding  their current working environment.

Instructor – Tom Hyland

Tom has been working in the medical device manufacturing and collagen processing field since 1981 and graduated in Chemistry/Chemical Engineering with Honours. Tom spent much of his early career with Johnston & Johnston and rose to Senior Operations, before working at SMT level for a number of pharmaceutical companies including Microsulis, Life Technologies and a Directorship at Collagen Solutions. He set up his consultancy, Hyland Enterprises, in 2011, where he has overseen projects in the UK, US and Australia.


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