Advanced Concepts in Contamination Control
Join us for a full-day event that combines presentations with interactive workshops, covering critical topics including biofilm detection and remediation, disinfectant efficacy validation testing, contamination control program design, mould management and evolving regulatory requirements.
Gain actionable strategies to maintain compliance, enhance cleaning processes and address complex challenges in critical environments. Exchange your knowledge, participate in Q&A sessions with presenters and engage in peer discussions to share experiences and gain valuable insights.
This event is ideal for professionals in pharmaceutical and biotechnology manufacturing, including those working in contamination control, quality assurance, microbiology, validation, cleanroom operations and related areas.
Meet the Presenters
Daniel Klein
Dan has over two decades of industry experience, including work in research and development for microbiology and clinical affairs, as well as managing a contract testing laboratory.
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He holds a master’s degree in biology and a bachelor’s degree in microbiology.
At STERIS Life Sciences, Dan provides technical expertise to Customers, helping troubleshoot and resolve contamination issues. He supports a wide range of critical processes and offers guidance on the latest developments in the industry. He also frequently presents data and technical insights at international industry meetings and sponsored events.
Dan is an active member of ASTM International, the Association for the Advancement of Medical Instrumentation (AAMI), the Parenteral Drug Association (PDA), AOAC International, the Institute of Environmental Sciences and Technology (IEST) and the Center for Biofilm Engineering (CBE). He previously served as Chairperson of AOAC International’s Committee on Antimicrobial Efficacy Testing, is an active participant in ASTM’s E35.15, E55.08 and D37 Committees and is a primary member of AAMI Work Group 08. Throughout his career, he has authored numerous peer-reviewed, industry articles and book chapters related to disinfection and sterilization.
Dave Shields
Dave has over two decades of professional microbiology experience, with expertise in food microbiology and aseptic manufacturing microbiology.
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He holds a master’s degree in management and a bachelor’s degree in biology.
Dave has authored numerous industry publications, delivered a wide range of webinars and contributes to the advancement of industry standards. He is an active member of the British Standards Institute (BSI) CH/216 Chemical Disinfectants and Antiseptics Committee, which is responsible for European disinfectant testing standards.
Jim Polarine Jr.
Jim has over three decades of industry experience, with expertise in cleaning, disinfection, microbial excursions and disinfectant validation and testing.
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He also has experience as a Clinical Research Manager with the Department of Veterans Affairs in St. Louis, Missouri, and as a Biology and Microbiology Instructor at the University of Illinois and McKendree University. He holds a master’s degree in biology.
At STERIS Life Sciences, Jim focuses on microbial control in cleanrooms and other critical environments. He delivers onsite training, webinars and high-level technical support for Customers in the biopharmaceutical industry, helping guide best practices in contamination control and disinfectant validation.
Jim is a recognized industry contributor and award recipient. He received the Parenteral Drug Association (PDA) Michael S. Korczynski Award in 2019 for advancing PDA’s international activities and the 2024 PDA Distinguished Service Award for leading the PDA Missouri Valley Chapter for four years. He has presented globally on cleaning and disinfection, microbial control in cleanrooms and disinfectant validation and has published multiple PDA book chapters and articles on contamination control. Jim served four years as President of the PDA Missouri Valley Chapter and is the current President Elect of the IEST Executive Board. He is also an active member of the International Society for Pharmaceutical Engineering (ISPE), the American Society for Microbiology (ASM), the Society for Industrial Microbiology and Biotechnology (SIMB) and several other industry associations.
Tracy More
Tracy has over 36 years of experience in pharmaceutical manufacturing, distribution, and regulation, gained from working within the industry as an EU QP and for the GMP Inspectorate of the UK medicines regulator (MHRA), where she reached Expert Inspector status.
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During her ten years at MHRA, Tracy played a pivotal role in developing and implementing regulations and European guidelines relating to pharmaceutical manufacture and distribution, including Annex 1, Annex 16 and Annex 21. She also led the agency data integrity and technology group, issuing guidance and looking at technology advancements. Her responsibilities also included the assessment of National Competent Authorities (JAP auditor as part of MRA work) and managing risk and noncompliance in these sectors with European and international collaboration, including during the COVID-19 pandemic.
Since leaving MHRA, she has provided consultancy and training to the pharmaceutical industry, National Competent Authorities, and partners.
We’re Here for You
Your needs are unique – so is our approach. Discover how a partnership with STERIS can reduce risk and improve sustainability and efficiency at your facility.
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