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Equipment Validation Online

Please check the entry requirements here before booking

Programme Overview: 

This course will run over 4 webinars (4 mornings) from 09:30 - 1.00pm

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 ab ove 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.

From €795.00 Booking

Contact us to get details
No. of attendees

Equipment Validation Online

  • No dates

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.