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.
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.
Linda Hendy works in Standard development with the National Standards Authority Ireland as a senior standard officer. Linda manages a number of national standard committees in the Healthcare area covering topics such as invitro-diagnostics, non-active medical devices, quality & risk management, sterilization, clinical laboratory testing and health informatics. Participating in national standard committees provide stakeholders with access to draft international standards relevant to their sector.
Prior to working in standard development Linda worked as an auditor with NSAI certification and Notified Body, carrying out quality management system audits and reviewing technical files as part of the CE Mark approval process.
Prior to working in NSAI Linda worked in the medical device industry as a Regulatory affairs and Quality Manger.
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.Show more
Joan O’Malley, Microbiology Business Development, Project Coordinator at Biologics Testing Solutions, Charles River Laboratories, Ireland. Joan has over 35 years’ experience in microbiological testing of biopharmaceutical, veterinary and medical device products. She has an extensive knowledge of guidelines and standards associated with QC testing and an understanding of industry expectations and requirements.
Joan has held positions in QC/Management in the Microbiology Department where she has an excellent track record in the area of FDA and EU GMP compliance audits.
Joan is now responsible for implementation of Rapid Microbiological Methods. Rapid Sterility methods implemented include - Celsis Advance/Celsis Adapt (Charles River) and BacT System (Biomerieux).
John currently works within the Equipment and Process Engineering team in the R&D department at Alcon’s Cork site. He has responsibility for the transfer and implementation of new equipment and process technology into the Alcon Ireland Intraocular lens manufacturing facility. In conjunction with the site sterilisation lead, he is also responsible for adoption of new products into Alcon’s qualified EO cycles as well as testing of legacy and new products with emerging modalities such as vaporised hydrogen peroxide.Show more