Network:
First Polymer Training Skillnet | Duration | 1 Day |
| Course Fee | €395. Inclusive of course manual, lunch and refreshments. |
| Subjects Taught | 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. |
| Course Content | 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. |
| Further Enquiries | Tel 090 6471223 Fax 090 6471221 Email: info@firstpolymer.com |
| Methods of Assessment | 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, time lines 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. |
| Trainer | TBA |
| Location of Course | First Polymer Training Skillnet |
Available to Job Seekers:
Yes
Certified:
No