19th October, 2020 - 22nd October, 2020 (4 days)
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
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 it must 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.
Recommended follow on course:
Who is the course for
- Validation Engineers
- Quality Engineers
- Planning Equipment commissioning
- Understand regulatory requirements
- Understand key elements that should be in Equipment Validation
- Understand IQ and OQ
- Layout of IQ and OQ protocol