Product and Process Validation

Dates: 7th November, 2022 - 11th November, 2022 (5 days)

Duration: 5 days

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

Accreditation: Product and Process Validation

Full Fee: €1195

Course code: 5N3044

Programme overview

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 and FDA QSR. The course aims to explore in some dept validation activities, the reasons of these activities and how best to meet these requirements.

All of these topics will be expanded on and Case Studies/Examples will be included in order to best communicate the method for validation.

We can deliver a shorter tailored programme at our centre in Athlone for you/or on-site if you have injection moulding capability there.

*A separate course is available in Computer Software Validation

Learning outcomes

  • Understand regulatory requirements around Validation
  • Understand in depth process validation activities, including cleaning and software

Who is the course for

  • Validation Engineers
  • Quality Engineers
  • Personnel planning validation activities

This course is designed for Senior Management, Quality Managers, Quality Engineers, QA and Regulatory personnel working on QMS’s in industry.

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 7.   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.  Process Validation

Module 16.  Exercise

Module 17.  Change Control

Module 18.  FMEA

Module 19.  Exercise

Module 20. DOE

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

Safety Shoes – Not required for this course

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


The assessment is comprised of a written exam on the last day of the course ( 30% of the total grade) plus an assignment that is due to be submitted 4- 6 weeks after the end of the course (70% of the overall grade). An exact date and submission link is given to each course participant, with full guidance and support given by the trainer. Trainees generally complete this assignment in their own time, over the 4-6 week period allocated.

5M3080 – Plastics Injection Moulding

ATP- Access, Transfer and Progression to our programmes

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