- 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.
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.