Dates:
2nd November, 2020 - 17th November, 2020 (10 days)
Duration: TBA
Location: Online
Accreditation: Certificate of Attendance
Full Fee: €1195
Course code: VALOL
Programme overview
This 5 day programme 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.
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
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
Find out how to achieve a Major Award in Injection Moulding (Level 5)
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
5M3080 – Plastics Injection Moulding
