Course details
CSV Course Topics /Agenda:
- Introduction to principles of validation, IQ, OQ, PQ, etc.
- Review of regulatory requirements
- Review of GAMP Guidelines
- Risk Analysis
- Categorisation of the computerised system & validation requirements
- Guidelines for determining validation effort with risk assessment
- Approach to new equipment and introduction of new equipment – “Life Cycle Approach”.
- Responsibilities within the validation project team.
- FMEA – a tool in validation approach.
- Validation Documentation: SOP, URS, SDS, FDS.
- Computerised Systems Life-cycle Project Phases.
- Categorisation of the computerised system & validation requirements
- Guidelines for determining validation effort with Risk Assessment Case Studies / Examples will be included in order to best communicate the methodology.
Who Should Attend:
This course is most suitable for those who wish to gain a good understanding of the principle and processes involved in computerised software validation and regulatory requirements.
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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