Product & Process Validation

Course Dates

Product & Process Validation

QQI CODE 5N3044. * This programme is a QQI component (minor) award, certified at Level 5 on the national framework of qualifications.

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.

Cost:
The cost of this course is €995 (10% discount for Plastic Ireland/IBEC members) 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.

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

DURATION:
9.15 am to 5.00 pm

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