Liz Brockson 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.

Talk Title: Case Study on Global Guidance for a Risk-Based Contamination Control Strategy

Abstract: EU Annex 1 emphasizes the need for a holistic Contamination Control Strategy (CCS) to ensure the safety of pharmaceutical products. This presentation will describe the basic principles, regulatory requirements, and industry best practices for the use of QRM in a contamination control strategy (CCS). Additionally, this presentation will provide an overview of one company’s novel approach for interpreting and implementing the Annex 1 CCS requirements to create a practical and compliant six-step approach to define and evaluate contamination controls, including a pragmatic approach to leveraging existing contamination controls. Furthermore, this presentation will describe a simple lifecycle management approach to ensure the CCS is maintained in an accurate state.