Kevin Fitzgerald CMIOSH, is an EH&S Professional with Boston Scientific supporting their Global Sterilization Business. Based in Galway, Ireland, Kevin has worked in Industry for the last 28 years, is a part time lecturer on the newly developed Diploma in Sterility Assurance at ATU and has been providing analysis and input for changing US & EU legislation in the Commercial Sterilization of Medical Devices.
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Richard has over 25 years’ experience in sterilization of medical devices, of which 18 years were in various quality, operations and EO technical roles at leading global contract sterilization provider, STERIS. In 2022 Richard moved back into the medical device manufacturing arena as International Sterility Assurance Program Director for Medline Industries, providing support to their extensive sterilization activities in Europe and Asia. Richard has also been actively involved in ISO TC198 WG1 since 2006 and was project leader for the development of ISO/TS 21387 – Guidance on Parametric Release for EO processing, published in 2020. In Dec 2022 he was appointed convenor of WG1 and is currently leading the revision of ISO 11135, which is targeted for publication in July 2024.
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Suzanne Butler is the Director of Sterility Assurance for EMEA, APAC & China manufacturing platform in Medtronic. Suzanne is responsible for supporting sterilization; EO, Steam, Gamma Radiation, E Beam Radiation & Dry Heat Processing as well as Microbiology for the manufacting facilities within the platform. She also performs both Supplier and Contract Manufacturing audits as a Subject Matter Expert. She is currently Chair of the Irish Medical Device Association (IMDA) Sterility Assurance Forum and is a member of ISO/TC 198/Working Group 1 on EO, Working Group 4 on BI’s and Working Group 8 on Microbiological Methods as well as AAMI ST working group 4 on BI’s.
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Margaret O’ Halloran is a Principal Scientist of Microbiological Quality and Sterility Assurance at Johnson & Johnson Vision, supporting all Vision Care and Surgical Vision manufacturing sites in the EU. In conjunction with J&J, she has lectured on the UCC Biopharmaceutical & MD Microbiology undergraduate course, and is member the J&J Sterilization Council which is an Enterprise function .Prior to joining J&J , she has held senior positions in various multinational MedTech companies with responsibilities for sterilization in EMEA, US and other global locations. In 2020, Margaret developed guidelines and protocols, and presented to a national audience on a manufacturing site’s response to the Covid-19 crisis in terms of contamination prevention and best practices. Margaret is the current Vice Chair of the IMA Sterility Assurance forum, and is an active member of multiple ISO working groups for sterility assurance. She is an advocate for innovation and development of the sector and has been the industry lead for development of the Postgraduate programme in End-to-End Sterility Assurance in association with Skillnet and ATU which launched in 2023.
Margaret has a background in the study of Science, Technology & Innovation, Operations Engineering , at NUIG, UCC and UL, and holds a MSc in Medical Device Regulatory Technology from NUI Galway and Sligo IT.
Dr Emer Sherry is Senior Executive with Irish Medtech since May 2022 leading the regulatory affairs workstreams including the QA/RA forums and the Task Forces. Prior to joining IMA, she held senior positions in Telecommunications Industry Ireland and Audiovisual Ireland within Ibec overseeing the regulatory affairs and public policy work streams. She represented industry on the Government’s Task Force on Mobile Phone and Broadband. She continues to lead the 5G work stream within Ibec. Emer is an active member of Medtech Europe’s MD and IVD Regulatory Affairs Committee. She holds a first-class honours degree in electronic engineering and a PhD in the same discipline from University College Dublin.
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Dr Ann O’Connell PhD is a visionary leader, a dynamic collaborator. As Head of Funded projects for Medtech and Engineering Skills with Ibec, Ann is responsible for funding, development and delivery of over 100 professional upskilling programmes ranging from 1-day webinars, to 2-year Masters programmes. Ann’s course list is wide ranging and comprehensive, covering Research & Development, Manufacturing & Digitalisation, Quality & Regulatory, Sustainability, and Management & Leadership, and she specialises in piloting and launching new programmes to meet emerging needs.
Ann completed her PhD in 2014 with the Centre for BioNano Interactions (CBNI) at University College Dublin and is a longtime advocate for lifelong learning amongst industry professionals. She joined Ibec in 2019 from Irish Manufacturing Research Centre, where as the European Programme Manager, she refocused strategy and investment and led the successful application of a proposal to coordinate a H2020 funded project under the ECSEL JU Program. Prior to that, Ann served as Senior Integration Engineer with Intel Corporation for almost two decades, supporting multiple business sectors across diverse geographies, Ann’s deep understanding of the power of technology, digitalisation, data science and intelligent automation in advancing all businesses is applied with expertise and purpose in her role today, as she supports the industries that will solve some of the world’s most critical health and environmental challenges.
“Knowledge is power, and we should never stop learning - especially as the challenges facing our world grow increasingly urgent. The knowledge we build today will trigger the discoveries of tomorrow, to empower solutions for our future”.
In 2023, Eoghan Ó Faoláin was appointed as the Director of Irish Medtech . the Ibec group which represents the medical technology sector. The Irish Medtech has more than 250 members, located throughout the island of Ireland. The group’s broad focus is to promote and support an environment that encourages the sustainable development and profitable growth of Ireland’s FDI and indigenous medtech companies. Eoghan has over 15 years’ experience with Ibec.
Previously Eoghan was the Head of Ibec Public Sector, supporting Ibec’s voluntary hospitals, further & higher education organisations and public sector bodies. Prior to that Eoghan held Acting Director and Senior Executive positions in Technology Ireland, the Ibec group representing the technology, software & ICT sectors. Eoghan joined Ibec as Regulatory Affairs Executive in the Irish Medical Devices Association (IMDA) in 2008.
Gerry is Senior Principal Quality Engineer in the Sterility Assurance team at the Galway Parkmore Medtronic facility. Gerry has over 25 years of industry experience in the pharmaceutical and medical device industries; 7 years of which has been at Medtronic. Gerry received his B.A. degree in Microbiology from the University College Galway. He is a Certified Industrial Sterilization Specialist to the AAMI Credentials Institute and holds accreditation for CISS-Ethylene Oxide.
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