Course Dates7th June, 2018 - 8th June, 2018 (2 days)
Training Benefits will include:
* Explanations regarding the regulations that govern the sector
* ISO 13485 – what is it?
* FDA – who are they and what do they require?
* Typical work practices required of operators
* Expectations for technical, scientific and management staff
* What is it like on the inside of a facility?
* Medical Devices in operation
* What are Class I, II and III devices?
* Typical employment conditions
* The controlled environment and room classifications
* Device ideas? – How they make it onto the market
* Device Design Systems
* Basic Problem Solving Techniques
* Good Manufacturing Practice.
Every participant will have the opportunity to identify their key requirements in advance of the course.
7 Centre Court, Blyry Business and Commercial Park, Athlone.
Who should attend?
Personnel who have minimal knowledge of the Medical Device Manufacturing sector and working environment but would like to understand what is expected. Suitable for personnel who may be interested in joining or converging with the medical device sector or for those who have just joined and would like a broad overview of the requirements.
COST: €795 per person.(10% discount for Plastic Ireland/Ibec members) including course manual, lunch and refreshments.
The successful completion of this programme by the learner does not lead to an award, but a certificate of attendance is issued to each participant.
Safety Shoes – Not Required on this course