Quality Training

Postgraduate Certificate in End-to-End Sterility Assurance (L9)

Objectives

This programme has been designed to meet the growing demands of companies in filling sterility assurance scientist and quality assurance operational roles. The impetus for the development of this specialist programme emerged from industry needs and the content has been developed in conjunction with a Sterility focus group comprised of industry sterility experts from Irish Medtech Association’s Sterility Forum.
The Postgraduate Certificate in Science in End-to-End Sterility Assurance will provide students with a detailed understanding of sterilisation methodologies applied to medical technologies in a range of contexts.
The programme will cover topics such as industrial microbiology, biocompatibility and cleanroom operations. In addition to current practices, the programme will include content on global trends in new sterilization methods.

Learners will also develop detailed knowledge of the regulatory requirements for sterilisation and the ability to source, interpret and apply standards for conformity. The programme will be delivered by both academics and key industry experts through a flexible blended approach, with induction taking place onsite in ATU. Lectures will be delivered online with practical demonstrations to be delivered at the later stages of the programme.

Content includes

The sterility assurance forum provides a platform for industry to input into developing and revising international standards relating to sterilisation methods and associated test methods utilised in the industry.

Topics include:
• Sharing sterility assurance best practice
• Product bioburden (human handlings)
• Auditing trends in sterilisation
• Clean room set up and more

Entry Requirements

Open to students who have obtained a Level 8 primary degree in a science/engineering subject related to the life sciences.

• Previous or current experience in sterility (minimum two years) will be considered in assessing entry qualifications for candidates with relevant Level 7 qualification with appropriate experience.
• Candidates who have completed modules in cognate programme areas may also enter the programme and gain exemptions as determined by the Programme Committee in accordance with the partner Institutions guidelines.
• Cases will be assessed on an individual basis by the Programme Committee.
• Students applying on the basis of formal qualifications and supplementary accredited prior learning (APL) for core pre-requisites will be required to submit full details and references to the Programme Board for consideration of educational equivalencies.
• Prior experiential learning will be assessed using guidelines recommended by the Academic Council of ATU Galway.
• Places are subject to approval by ATU Galway.

The programme will employ a blended learning approach involving synchronous and asynchronous online lectures. Lectures are delivered on a weekly basis to students using Microsoft Teams. Students who cannot attend the live lectures may view the recorded lectures anytime, with links to the recordings placed on the Moodle page for the respective subject. Moodle acts as the virtual learning environment (VLE) whereby students enrol on a VLE page for a respective subject and lecturers provide learning materials, notes and handouts to them via the VLE.

The blended delivery format proposed for this programme includes online (synchronous and asynchronous learning), as well as workshops, group project work, case studies and variety of other teaching and learning tools. Practical components include site visits to industry facilities and are confined to the final week of each semester


THE PROGRAMME WILL BE DELIVERED OVER ONE ACADEMIC YEAR:
SEMESTER 1:
• Industrial Microbiology
• Cleanroom Technology, GMP & Water Systems

• Terminal Sterilisation for Medtech Sector (Year-long)

SEMESTER 2:
• Global Sterilisation Trends for Medtech Industry
• Quality Management, Regulatory Affairs &
Biocompatibility

• Terminal Sterilisation for Medtech Sector (Year-long)

Qualification

Upon successful completion of the programme, participants receive a level 9 Postgraduate Certificate (30 ects) in Science in End-to-End Sterility Assurance and are eligible to enrol in the newly developed Master of Science in End to End Sterility Assurance Programme.

Upcoming dates: