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 www.nfq.ie 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.
