Dates:
To be verified.
Duration: This course will run over 4 webinars ( 4 mornings) from 09:30 - 1.00pm
Location: 7 Centre Court, Blyry Business and Commercial Park, Athlone.
Accreditation: Certificate of Attendance
Full Fee: €450
Course code: EQOL
Programme overview
This course is designed to provide a detailed understanding of equipment validation for regulated industries. If you purchase or develop a new piece of equipment that is used to manufacture medical devices, in-vitro medical devices, or pharmaceutical products EU and FDA regulations require that firms have a quality system programme in place for the following•
- Calibration and maintenance of equipment
- When equipment is installed it must be done correctly against best industry practice to ensure it operates as intended against URS ( User Requirement Specification), FDS ( Functional Design Specification), and to ensure proper SAT (Site Acceptance Testing) and FAT (Factory Acceptance Testing) is completed.
- This equipment must pass through the above toll gates to be considered ready for PQ
( Performance Qualification) testing and generation of a design space for that process. This design space must consider the key inputs to the process which can be developed by carrying out the design of experiments using Orthogonal arrays. - You then must guarantee reproducibility of the process by carrying out validation studies with this equipment.
We can deliver a shorter tailored programme at our centre in Athlone for you/ or on-site if you have injection moulding capability there.
Recommended follow on course:
Who is the course for
- Validation Engineers
- Quality Engineers
- Personnel
- Planning Equipment commissioning
Learning outcomes
- Understand regulatory requirements
- Understand key elements that should be in Equipment Validation
- Understand IQ and OQ
- Layout of IQ and OQ protocol
Course Content
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 8. 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. Change Control
Module 16. FMEA
Module 17. Exercise
Module 18. 21CFR Part 11
Trainer Profile
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