Certificate in Computerised Systems and Data Quality for Medtech

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 todays 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.