Course details
COURSE DETAILS:
- Key Principles of Risk Management
- Introduction to ISO 14971:2007
- FMEA, FMECA
- Identifying Risks/Hazards
- Residual Risk – is this acceptable?
- Estimating and reduction of Risks
- Change Control and estimation of risk
- Group FMEA Assignments
- Product Life Cycle Management
- Product Design Phase
- Product Production Phase
- Post Production Review- Customer feedback, Substitutes evaluation, Competitor evaluation and Clinical Review
- Product Risk Management Self Certification and Technical files
- Technical File Management of Risk
WHO SHOULD ATTEND
This course is designed for Senior Management, Product Design Managers, Engineers, Manufacturing Cell Business Owners, QA and Regulatory personnel in the medical device industry.
Updated on 08 November, 2015Course Location
About First Polymer Training Skillnet
First Polymer Training (FPT) Skillnet operates as a training network for the Plastics Industry in Ireland and is funded under the government’s Skillnets initiative. The aim of FPT Skillnet is to deliver training that is focused on the specific needs of the plastics industry and includes certification and development.
Initiated by Plastics Ireland, FPT Skillnet’s objective is to provide technical training to polymer processors, both at our centre in Athlone and in-company as required. Our administrative and course centre is now located at 7 Centre Court, Blyry Business and Commercial Park, Athlone.
A full range of plastics processing equipment is available including Fanuc (100 tonne Electric), Krauss Maffei (100 tonne Hydraulic) and Demag (25 tonne Hydraulic) moulding machines. They are delighted to announce Arburg UK have replaced the ARBURG ALLROUNDER 320C 500 170 50 tonne machine with a new ARBURG ALLROUNDER 420C 1000 290 100 tonne golden Edition machine. This machine is equipped with the latest SELOGICA Direct touch screen control.
Having a full range of plastics processing equipment on site allows FPT to deliver intensive hands on training.
How can They meet your company’s needs?
First Polymer Training Skillnet organises a calendar of courses which are delivered at our centre in Athlone. These courses are advertised regularly. HoTheyver, if your company has specific needs They can design a course to meet those needs or modify an existing course to deliver in-company.
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