Design of a Global Sterility Assurance Program

Sterility assurance is an essential component of a contamination control strategy for aseptic processes and manufacturers of sterile products. With the recent revisions to Annex 1 heavily emphasizing the importance of a contamination control strategy for manufacturers, Takeda sought to enhance sterility assurance for aseptic production sites as well as aseptic practices for low bioburden manufacturing sites. The program was developed via a design thinking methodology with quality and manufacturing subject matter experts from global sites coming together in a workshop approach to define current challenges and potential opportunities for the sterility assurance program. The program was designed to be a collaboration between global and local functions to support standardization, harmonization, and implementation of best practices across aseptic manufacturing sites. Ultimately, the program will offer training and capability building on sterility assurance and aseptic practices throughout the network.

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 7 years of experience in FDA-regulated businesses as a quality assurance and quality control technical professional. In her current role, Liz is responsible for leading the design and implementation of Takeda’s global manufacturing sterility assurance program. Liz holds a Bachelor’s degree in animal sciences and a master’s degree in public health, both from Ohio State University.

Followed by Vanessa Vasadi-Figueroa, Executive Director of Microbiology and Sterility Assurance at Quality Executive Partners

Vanessa Vasadi-Figueroa, Executive Director of Microbiology and Sterility Assurance, has more than 17 years of combined experience in the life sciences industry, supporting pharmaceutical, biotechnology, and medical device companies. Mrs. Figueroa’s core expertise is rooted in sterility assurance, contamination control, environmental and utility monitoring programs, and quality control laboratory management. Her consulting experiences have spanned both domestic and international top ten pharmaceutical companies, applying both US and global regulatory standards of quality. She has authored several publications and co-developed Virtuosi®, the world’s premier, revolutionary, and one-of-a-kind education and training product for the life sciences. Mrs. Figueroa has a bachelor’s degree in molecular biology from State University of New York at New Paltz and a master’s degree in molecular biology and microbiology from San Jose State University. She is an active and publishing member of several professional organizations, such as the Parenteral Drug Association, the American Society of Microbiology, and the Association for Women in Science.

Sponsored by Quality Executive Partners and Virtuosi

About Quality Executive Partners
Quality Executive Partners, Inc. (QxP) is a global management and technical GMP consulting firm providing the pharmaceutical industry with innovative solutions and revolutionary technical education programs, including Virtuosi®, an on-demand education and virtual-reality simulation training platform. The mission of QxP is to ensure our clients meet their business, quality, and compliance goals simultaneously. We achieve this through a unique partnering relationship that provides technical expertise, educational tools, mentoring, and execution support. Our success is defined by providing timely delivery of those goals coupled with the transfer of knowledge and capability to the client’s team.

About Virtuosi
Virtuosi is the world’s first and only comprehensive multi-language, on-demand education and virtual-reality simulation training platform for the pharmaceutical and biotech industries. The platform combines 56 in-depth technical courses in Sterile Manufacturing, Microbiology, Cell and Gene Therapy / ATMP with 26 highly immersive virtual reality experiences through which employees apply and practice the techniques they learn. Virtuosi is available in English, French, German, Spanish, and Swedish. Virtuosi is used by large and small pharmaceutical and biotech companies around the globe.