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.
- Explain the phases of a validation to include Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)
- Outline the requirements of relevant governing bodies such as Food and Drug Administration (FDA), International Standards Organisation (ISO), notified bodies and Health Product Regulatory Authority (HPRA)
- Describe the positive benefits of developing a design space and their influence on process stability and process capability
- Explain the various validation rationales to include: grouping rationales for validation, lifecycle approach for utilities, process, software and method
- Summarise how a cleaning validation is planned, designed and executed
- Utilise guidance documents such as ISO EN 13485 to apply the appropriate legislation as required
- Use a validation flowchart to demonstrate the chronology of the documentation in a Master Validation Plan (MVP)
- Analyse the results of either a design of experiments (DOE) or a failure mode effect analysis (FMEA) study
- Illustrate by the use of examples or case studies how to construct validation protocols and reports
- Design a complete complex validation protocol including IQ, OQ and PQ, providing all relevant documentation
- Apply GAMP methodology to execute software validation
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.
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
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.