Dates:
13th September, 2021 - 28th September, 2021 (10 days)
Duration: This course will run over 10 mornings from 09:30 - 1.00pm ( with breaks) over 3 weeks - Live online training.
Location: Online
Accreditation: QQI Product and Process Validation
Full Fee: €995
Course code: VALOL
Programme overview
This course is normally held over 5 day face to face. We are now running this course online over 10 mornings. This course is designed to provide 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 validation activities, the reasons of these activities and how best to meet these requirements.
All of these topics will be expanded on and Case Studies/Examples will be included in order to best communicate the method for validation.
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
Recommended follow on courses are:
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.
Learning outcomes
- Understand regulatory requirements around Validation
- Understand in depth process validation activities, including cleaning and software
- Understand structure of Protocols, Test Reports, Master Validation Plan, User Requirement Spec
Course content
| Module 1 | Background and History | Module 14 | Validation of Tooling |
| Module 2 | Current Legislative Requirements | Module 15 | Process Validation |
| Module 3 | Validation Management | Module 16 | Exercise |
| Module 4 | Exercise | Module 17 | Change Control |
| Module 5 | Validation Description Type | Module 18 | FMEA |
| Module 6 | Exercise | Module 19 | Exercise |
| Module 7 | When to Qualify and Validate | Module 20 | DOE |
| Module 8 | User Requirement Spec | Module 21 | Software Validation |
| Module 9 | Test Protocol | Module 22 | Design Control Validation |
| Module 10 | Exercise | Module 23 | Clinical Validation |
| Module 11 | Alignment of Operation, Validation and Calibration parameters | Module 24 | Cleaning Validation |
| Module 12 | Validation Test Report | Module 25 | Validation Certificate |
| Module 13 | Operational Qualification |
Trainer Profile
TP Lowry has over thirty years in medical device and pharma industries working as Analyst, Engineer, Quality Manager to Operations Director. Consultant for the past sixteen years.
MBA , Doctor of Quality Management
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