21st October, 2019 - 22nd October, 2019 (2 days)
Duration: 2 days
Location: 7 Centre Court, Blyry Business and Commercial Park, Athlone.
Accreditation: Certificate of Attendance
Full Fee: € 795 per person including course manual, lunch and refreshments.
This course is designed to provide 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 that it is 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 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.
- Understand regulatory requirements
- Understand key elements that should be in Equipment Validation
- Understand IQ and OQ
- Layout of IQ and OQ protocol
Who is the course for
- Validation Engineers
- Quality Engineers
- Planning Equipment commissioning
- 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
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