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.