Contact Details
Phone: 00 353 (0)90 6471223       Email:

Product & Process Validation

Course Dates

17th June, 2019 - 21st June, 2019 (5 days)

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. The course aims to explore in some depth validation activities, the regulatory reasons of these activities and how best to meet these requirements.Validation QQI

The cost of this course is €1195  including course manual, lunch and refreshments.

Course Topics:

  1. Process Control – how we control processes – Line clearance, first piece, line checks and final order inspection – does this control every part we make?
  2. Why is validation necessary to guarantee reproducibility?
  3. Principles of validation.
  4. Drafting User Requirements Specifications (URS) and  Functionality Specifications(FS).
  5. Review of regulatory requirements: ISO EN 13485:2012, FDA QSR’s, Guidance Documents
  6. The Validation Flowchart – process map
  7. The use of Tools for product and process validation: FMEA, DOE, etc.
  8. Master Validation Plan (MVP)
  9. Installation Qualification
  10. Operational Qualification, Worst Case Scenario, Operational Windows
  11. Equipment IQ/OQ- using URS and FS
  12. Performance Qualification- Design Space generation – rationale for selecting certain inputs
  13. Design Validation
  14. Clinical Testing and Validation
  15. Design of Experiments – how to execute one
  16. Process Qualification / Validation
  17. Grouping Rationales for Validation
  18. Responsibilities within the validation project team.
  19. Validation Documentation Stages and documents: SOP, MVP, IQ, OQ, PQ ; Protocols and Reports
  20. Some Compliance Issues relating to Validation
  21. Life Cycle approach to validation projects
  22. Computerized System Validation, Automation *
  23. Retrospective Validation
  24. Cleaning Validation*
  25. Risk Assessment & Validation
  26. Q & A Session
  27. PDCA ( Plan Do Check and Act)  and Validation
  28. Life Cycle Approach to Validation
  29. Preparing for regulatory compliance

* A separate course is available in Computer Software Validation. All of these topics will be expanded on and Case Studies / Examples will be included in order to best communicate the method for validation.

7  Centre  Court, Blyry Business and Commercial Park, Athlone.

Safety Shoes – Not required for this course

9.15 am to 5.00 pm

Name of Awarding Body: Quality and Qualifications Ireland QQI

Title of Programme: Product and Process Validation

Award to which it leads: Product and Process Validation

QQI Code: 5N3044

Find out how to achieve a Major Award in Injection Moulding (Level 5)

This programme is a QQI component (minor) award, certified at Level 5 on the national framework of qualifications – see  and is an elective component of major awards

  • 5M3080 – Plastics Injection Moulding
  • 5M3067 – Plastic Extrusion Blow Moulding
  • 5M3074 – Plastics Extrusion. 


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