Product & Process Validation
Course Dates
15 November 2010 - 16 November 2010Product & Process Validation
This 2 day programme is designed to provide detailed understanding of the process of validation for regulated industries, with particular focus on validation for the manufacture of medical devices and the requirements of ISO EN 13485. The course aims to explore in some depth validation activities, the regulatory reasons of these activities and how best to meet these requirements.
Cost:
The cost of this course is €795 which includes course manual, lunches and refreshments.
Course Topics:
- Short review of principles of validation.
- Review of regulatory requirements: ISO EN 13485, QSR, Guidance Documents
- The Validation Flowchart
- The use of Tools for product and process validation: FMEA, DOE, etc.
- Master Validation Plan (MVP)
- Installation Qualification
- Operational Qualification, Worst Case Scenario, Operational Windows
- Equipment IQ/OQ
- Performance Qualification
- Process Qualification / Validation
- Grouping Rationales for Validation
- Responsibilities within the validation project team.
- Validation Documentation Stages and documents: SOP, MVP, IQ, OQ, PQ ; Protocols and Reports
- Some Compliance Issues relating to Validation
- Life Cycle approach to validation projects
- Computerised System Validation, Automation *
- Retrospective Validation
- Cleaning Validation
- Risk Assessment & Validation
- Q & A Session
VENUE:
First Polymer Training,
7 Centre Court, Blyry Business and Commercial Park,
Athlone
Co. Westmeath
DURATION:
9.15 am to 5.00 pm
2 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)
BED AND BREAKFASTS: Burren Lodge – Mrs. Linnane 090-6475157 (also very convenient to our centre) Shelmalier House – Mrs. Denby 090-6472245
*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 opportunities for the career development of Engineers Ireland (EI) members.
Each FPTS course attended allows EI members to gain credits under the CPD scheme.
