Validation Principles and Practices for the Medical Technology Sector
The Irish Medtech Association Skillnet and contracting organisation, the Irish Medtech Association, the Ibec group that represents the medical technology sector and Reidh Consulting group in collaboration with University of Limerick are delighted to present the new Validation Principles and Practices programme for the medical technology sector.
This programme has been designed to meet the growing requirements of Irish companies in filling validation roles and is delivered through blended learning. The impetus for the development of this specialist programme emerged from industry needs and the content has been developed in conjunction with a taskforce comprised of validation experts from medical technology sector.
The course will enable personnel in the medical technology industry to understand all current device and diagnostic validation regulations and to develop the skills necessary to address and prepare for the scope of validation requirements in industry.
The Validation professional is critical to making safe and effective medical products available to patients worldwide. These professionals ensure compliance to international medical device regulations for designing and manufacturing medical device products.
The aim of the course is to introduce participants to the fundamentals of Validation, providing them with a basic knowledge of the regulations, standards and the skills necessary for validation work in the Medical Device sector. This course will cover international validation requirements pertaining to validation and all associated systems.
The course content will follow the following themes:
· Quality Management Systems and where validation aligns to the Quality Management Systems.
· Validation and certification bodies’ requirements within Validation.
· Writing best practice protocols and documentation.
· Risk, risk management and compliance within Validation.
· The key elements of validation throughout the lifecycle of a medical device product.
· Support systems required to maintain a validated state.
Validation professionals are one of the most in-demand professions in the Medical Device Industry. This module allows for professionals in the medical device industry and those with an interest in validation to develop the fundamental skills to contribute as effective members of a validation team in the medical devices sector.
Duration: 12 weeks – 3 Classroom days, 9 weeks on-line
On-line classes require 2 Hour lecture on line plus additional 5 hours (approximate) of research, reading and assignments. Tutor support will be available for on-line classes in the form of a tutorial (approx. 1 hr). On-line material will be released in advance and students are expected to have completed the material for the tutorial. Approximately 90 – 100 hours of study are required outside of the course work.
Introduction to the Course and Introduction to Validation
Validation Regulations & Introduction to Risk Management
On-Quality Risk Management Practical & Design Validation
Documentation Practices & Sterilization
Generating and Executing Protocols
Computer System Validation & Project Discussion
Test Method Validation & Sampling
Process Validation Statistics & Verification and Validation
Validation Lifecycle & Cleaning Validation
Supplier Qualification & Maintaining a Validated State
Case Study Presentation
Submission 4,000 word dissertation
Entry requirement will be minimum Level 7 with two years’ experience working in a regulated environment.
Prior experiential learning will be assessed using guidelines recommended by the Academic Council of University of Limerick.
Accredited by the University of Limerick Upon successful completion of the programme, participants receive an award at NFQ Level 8