Evolving Cleaning and Disinfection Standards: The Impact on Your Contamination Control Program

Jim has over three decades of industry experience, with expertise in cleaning, disinfection, microbial excursions and disinfectant validation and testing.

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.

Dr. Subrata Chakraborty is a globally recognized pharmaceutical consultant, auditor, and trainer with over 30 years of industry experience. He is the Founder and CEO of INOPHAR Consulting & Training and INOVR®, leading science-driven initiatives in pharmaceutical operations, quality systems, capability building and immersive learning.

He is a member of the PDA’s esteemed Science Advisory Board (SAB), contributing to global scientific discussions, technical report development, and regulatory commentaries. He also leads the Sterile Processing Interest Group for the APAC region within PDA.

Over his career, he has held leadership roles at multinational organizations including Pfizer, Novartis, Fresenius Kabi, and Cipla. He is widely recognized for his expertise in Quality Systems, Risk Management, Contamination Control, Sterilization, Aseptic Processing and Operational Excellence and remains actively engaged in global forums focused on process design and regulatory alignment.