Developing a Site-Wide Contamination Control Strategy: From Risk Mapping to Implementation

Recent revisions to EU GMP Annex 1 have significantly reshaped expectations for contamination control strategy (CCS), requiring manufacturers to adopt a holistic, risk-based approach. This poster presents a real-world case study from a global pharmaceutical company that has implemented a novel, structured framework for CCS development and deployment. The approach includes standardized global risk questions, tools for consistent assessment, and guidance for lifecycle management. The result is local CCS programs that align with the global CCS strategy with execution through scalable templates and practical implementation tools, enhancing compliance and supporting long-term contamination control

Presented by Joseph Horvath, PhD, Head of Quality Risk Management at Takeda Pharmaceuticals

Joe Horvath is Head of Quality Risk Management at Takeda Pharmaceuticals.  He was previously Head of Quality IT Systems at Takeda and Senior Director, Quality Systems at Millennium Pharmaceuticals.  Before joining Millennium, Joe was an Executive Consultant in the Knowledge Management practice of IBM Consulting Group (now IBM Global Services) where he worked with pharmaceutical companies and conducted multi-client research within the IBM Institute for Knowledge Management.  Before joining IBM, he was a post-doctoral student and Associate Research Scientist at Yale University.  He received his Ph.D. in Cognitive Science from Brown University.

Presented by Liz Brockson, Aseptic Processing and Sterility Assurance Lead in Global Sterility Assurance and Microbiology at Takeda

Liz Brockson is an Aseptic Processing and Sterility Assurance Lead in Global Sterility Assurance and Microbiology at Takeda and is based out of Minneapolis, MN. Liz has a background in benchtop microbiology and immunology, as well as over 12 years of experience in FDA-regulated businesses as a quality assurance and quality control technical professional. In her current role, Liz is responsible for enhancing contamination control and sterility assurance globally. Liz holds a Bachelor’s degree in Animal Sciences and a Master’s degree in Public Health, both from The Ohio State University.

Followed by a live Question and Answer Session