Certificate in Science in Computerised Systems and Data Quality for MedTechOpen for applications on www.gmit.ie
Discipline: Analytical, Biopharmaceutical and Medical Science
Location: Galway - Dublin Road
NFQ Level: 8
Programme Duration: One year
Mode of Study: Blended Learning
Application Route: Apply direct to GMIT
Entry Requirements: Level 7 Major Award in Engineering, Science or related disciplines
- The aim of this special purpose award is to provide students with the skills required to add value in an ever-evolving manufacturing environment (with a focus on medical device manufacture).
- All aspects of medical device manufacturing and quality management is becoming more and more dependent on automation. Software and automation are present everywhere in today’s manufacturing environment, from increasingly sophisticated equipment, to automated business process flows in ERP (Enterprise Resource Planning) systems, and the management of a myriad of data from analytical test outputs to quality trend analysis and other management data.
- This course will cover the key area of validation of software and automated systems.
- There will be a significant emphasis on actual industry examples and opportunities for participants to practice what they learn in workshop-style classes and assignments.
- Validation documents will be created by the students and critiqued as they would be in industry, leaving the learner in a much more confident position to take up a validation role.
- Learners will also cover data and the importance of data integrity in a regulated environment.
- There is a well-documented increase in the regulatory focus on data and the management thereof. There will be a focus on the integrity of data.
- As there is much growth, development and innovation in this area, it is timely to include a module on Emerging Software Trends, which will cover topics, from the evolving definition of a medical device to include software; to innovations in machine learning and artificial intelligence.
- We have a highly experienced lecturing team and strong industry partnerships to support this module and the added benefits of guest lectures and real industry examples.
View the 2020/21 Course Brochure here
Open for applications on www.gmit.ie. Start date will be January 2022.
- Software and Automated System Validation - download module details here (PDF)
- Data Use and Integrity - download module details here (PDF)
- Validation Project Management - download module details here (PDF)
- Emerging Software Trends - download module details here (PDF)
On successful completion of this programme the learner will/should be able to:
- Appreciate all the dependancies on software and data throughout manufacturing and explain the integration points of validation across a Quality Management System.
- Have knowledge of software development life cycles, for software, computerised systems and automated systems within in a manufacturing context.
- Explore the application of advancing technologies like artificial intelligence and machine learning in medical device development and manufacturing.
- Transform software and data quality regulatory requirements into practical and useable procedures and tools for a pragmatic approach to regulatory compliance.
- Plan a validation project, including boundary definition, assignment of specific responsibilities, activity planning, ensuring stake-holder buy-in.
- Research complex emerging technologies and trends within the Medtech software area.
- Understand the regulator’s / auditor’s perspective on advancing application of software and data in the context of healthcare.
- Create planning, specification and verification documents individually and as part of a multi-disciplinary teams.
- Reflect on emerging Medtech software trends and technologies explored with industry guests and develop ideas on future applicability.
Course Start Date
10th January 2022
10th December 2021
Blended, a combination of classroom and online lectures (subject to health and social distancing rules)
Applications can be made online at https://apply.gmit.ie, please select application type L8.
Places will be awarded on academic merit. If all places are not filled by those holding the entry requirement, Recognised Prior Learning may be offered to those not holding the entry requirement.
School: School of Science
Department: Department of Biopharmaceutical and Medical Science
Head of Department: Dr.Eugene McCarthy
For applications contact:
Department of Graduate Studies and Professional Development
Galway-Mayo Institute of Technology