Postgraduate Certificate in End-to-End Sterility Assurance

This programme has been designed to meet the growing demands of companies to fill senior sterility assurance scientist and quality assurance roles. Content has been developed in collaboration with a sterility focus group comprised of industry sterility experts from the Irish Medtech Associations Sterility Forum and ATU Galway.

The programme aims to develop an in-depth knowledge and understanding of sterility assurance methodologies for medical technologies in a range of contexts. This programme will enable learners to develop a deep knowledge of Innovation in sterility assurance for medical technologies, including new techniques and global trends in technology and sustainability along with concepts of industrial microbiology in controlled settings and principles of biocompatibility and biological evaluations for sterility assurance. Learners will also develop report writing, analytical, and problem-solving skills for a lifelong career in sterility assurance. Executive leadership strategies and advanced methodologies for managing innovation to drive business growth is also a core part of this programme. Learners will develop advanced skills in research and the ability to interpret and implement regulations and quality standards for conformity within the Medtech sector.

Students will study 4 modules per semester. Students will typically have 6 to 7 one-hour live, recorded lectures per week. A schedule of the lecture times and associated assessments/site-visits dates will be communicated to students at the beginning of each semester. Material delivered for each module will be supplemented by additional reading material (Book list; Journal Resources; On-line Resources). Students will engage up to 4 hours independent learning per module per week, which includes self-directed learning activities associated with assessments and assignments.

Assessment of students will be based on 100% continuous assessment with assignments throughout the course in conjunction with submission of the applied research project at the end of the year.