Скачать или смотреть End-to-End Sterility Assurance Training: Industry Veteran's Perspective with Caroline Walsh

Caroline Walsh, Senior Director of Quality Assurance and Regulatory Assurance at Aerogen, shares her perspective on the Postgraduate Certificate in End-to-End Sterility Assurance, from Irish Medtech Skillnet which was developed in collaboration with ATU Galway, the Irish Medtech Association, and the Sterility Assurance Industry Working Group established in 2021.

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 Assurance industry working 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 sterilisation 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 lectures online and 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 blended delivery format offered 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.

About Irish Medtech Skillnet
Irish Medtech Skillnet is a learning network for companies of all sizes in the medical technology and engineering sector operating in Ireland. We provide Technical, Regulatory and Management training for Irish-based Medtech companies of all sizes, which is either subsidised or fully funded through Skillnet Ireland from the National Training Fund, through the Department of Further and Higher Education, Research and Science.

The mission of our national network is to enhance Ireland’s position as an emerging global medical technology hub by developing a strong talent base and enhancing the specialised knowledge and skills that exist within the sector.

Visit www.irishmedtechskillnet.ie to learn more about our expansive range of training programmes.