This 5 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 and FDA QSR. The course aims to explore in some dept validation activities, the reasons of these activities and how best to meet these requirements.
All of these topics will be expanded on and Case Studies/Examples will be included in order to best communicate the method for validation.
We can deliver a shorter tailored programme at our centre in Athlone for you/or on-site if you have injection moulding capability there.
*A separate course is available in Computer Software Validation
- Understand regulatory requirements around Validation
- Understand in depth process validation activities, including cleaning and software
Who is the course for
- Validation Engineers
- Quality Engineers
- Personnel planning validation activities
This course is designed for Senior Management, Quality Managers, Quality Engineers, QA and Regulatory personnel working on QMS’s in industry.
Module 1. Background and History
Module 2. Current Legislative Requirements
Module 3. Validation Management
Module 4. Exercise
Module 5. Validation Description Type
Module 6. Exercise
Module 7. When to Qualify and Validate
Module 8. User Requirement Spec
Module 9. Test Protocol
Module 10. Exercise
Module 11. Alignment of Operation, Validation and Calibration parameters
Module 12. Validation Test Report
Module 13. Operational Qualification
Module 14. Validation of Tooling
Module 15. Process Validation
Module 16. Exercise
Module 17. Change Control
Module 18. FMEA
Module 19. Exercise
Module 20. DOE
TP Lowry has over thirty years in medical device and pharma industries working as Analyst, Engineer, Quality Manager to Operations Director. Consultant for the past sixteen years.
MBA , Doctor of Quality Management
Safety Shoes – Not required for this course
This programme is a QQI component (minor) award, certified at Level 5 on the national framework of qualifications – see www.nfq.ie and is an elective component of major awards
The assessment is comprised of a written exam on the last day of the course ( 30% of the total grade) plus an assignment that is due to be submitted 4- 6 weeks after the end of the course (70% of the overall grade). An exact date and submission link is given to each course participant, with full guidance and support given by the trainer. Trainees generally complete this assignment in their own time, over the 4-6 week period allocated.
5M3080 – Plastics Injection Moulding