Computerised Software Validation
Course Dates
11 November 2010 - 11 November 2010Cost: €395 (10% discount for Plastic Ireland members)
Inclusive of course manual, lunches and refreshments.
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.
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.
Venue:
First Polymer Training,
7 Centre Court,
Blyry Business & Commerical Park,
Athlone,
Co. Westmeath
DURATION:
1 day course.
CONVENIENT HOTELS:
Creggan Court Hotel, Athlone Tel: 090-6477777 (2 mins by car)
Radisson SAS, Northgate Street, Athlone. (Book through us for a special rate)
*This programme is a FETAC component (minor) award, certified at Level 5 on the national framework of qualifications (www.nfq.ie ).
The assessment at the end of the programme, if successfully completed, will lead to one credit towards a major(compound) award, of which 8 credits are needed in total. Please see How to achieve a FETAC major award with FPT. Some of our programmes have assignments as part of the assessment which should be completed by the learner after the programme has finished. Full instructions, timelines and ongoing guidance will be given by the course tutor. Most assessments are completed during the programme and results will be made available to learners as soon as they have gone through our Quality Assurance procedures and final submission to FETAC.
Please see our Protection for Learners Policy
Engineers Ireland CPD Scheme
In 2009, FPTS became a registered training provider with Engineers Ireland, recognising FPTS as a training provider who offers relevant learning oppurtunities for the career development of Engineers Ireland (EI) members.
Each FPTS course attended allows EI members to gain credits under the CPD scheme.
