Learning outcomes

• 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.

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.