Product and Process Validation

Dates: 6th March, 2023 - 10th March, 2023 (5 days)

Duration: 5 days

Location: 7 Centre Court, Blyry Business and Commercial Park, Athlone N37 RT29

Accreditation: Product and Process Validation

Full Fee: €1195

Course code: 5N3044

Programme overview

This 5 day programme is designed to provide a 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 depth:


  • All validation activities;
  • the reasons for these activities and;
  • how best to meet these requirements and methodologies.


All of these topics will be expanded on and case studies/examples will be included in order to best communicate the method for validation.


Not what you are looking for: FPT can design bespoke shorter programmes for companies to be delivered at our Athlone Centre or on-site depending on any specific needs. Please get in touch to discuss further.

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 experience in the international medical device and pharmaceutical industries working as an Analyst, Engineer, Quality Manager and Operations Director. He has been a highly sought after Consultant for the past sixteen years. He holds an MBA, Doctor of Quality Management.

Assessment & Accreditation

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.

ATP- Access, Transfer and Progression to our programmes

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