Course details
Who should attend?
Personnel in Quality, Design, Regulatory, Engineering, Operations and Suppliers to the medical device industry who are responsible for managing, implementing and using Medical Device Systems which may be subject to FDA Inspection.
Training Benefits will include:
- First hand information on FDA Inspection experiences
- 21 CFR Part 820 – implementing all of the requirements into your system
- Key issues everyone in the organisation should know
- A system V’s records focused inspection
- The Quality System Inspection Technique – QSIT
- How to evaluate your overall state of compliance
- Closing the gaps
- The Team factor
- Project Management of preparations
- Consequences of a poor inspection result
- Identifying appropriate Front-Line personnel for the inspection
- During the audit – key watchouts
- The format of the 483 observation
- The FDA Warning Letter
- Responding to Observations
Every participant will have the opportunity to identify their key requirements in advance of the course.
Free inpidual follow up consultation will be available post training from your course tutor.
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.
See all First Polymer Training Skillnet courses- EUR 39
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