March 13-14, 2019, San Diego, CA
Ana Fonseca is a Principal Scientist working in Quality Control for over 25 years. She has worked for large Pharmaceuticals with solid and liquid dosage forms manufacturing operations, and small Biotechnology companies with Aseptic Manufacturing. Ana manages projects such as qualification of cleanliness zones classified areas, implementation of environmental monitoring programs using a risk based approach to meet ISO, Annex 1 and ATMP regulations, developing and validating Microbiological methods for release testing, disinfectant efficacy and hold time studies, and technical transfers of assays from US to EU. Ana has been involved with review of CMC Regulatory submissions, and she is the Microbiology Subject Matter Expert interacting with inspectors during FDA, EMA, TGA, HC and PMDA Regulatory audits, internal departments and CMOs.
Ana has worked for three companies (ImClone, Dendreon and Novartis Cell & Gene Technical Development and Manufacturing) with breakthrough cancer treatments, such as a monoclonal antibody and personalized immunotherapies. Ana was involved from the early stages of clinical development to Regulatory approvals. This has been the most evolving and rewarding part of her career, working so closely with cancer patients and hearing of their recovery has been the most inspiring. Ana has also been involved in community volunteer work, she served as President for the Elizabeth Portuguese Lions Club, associated with the Lions Clubs International.
Ana holds a Bachelor’s degree in Biology from Montclair State University. She speaks and writes fluently in English and Portuguese.
Amir Zandnia is currently Senior Project Engineer at Fresenius Kabi USA, LLC. In his role he serves as the Technical lead for initial design, commissioning, validation and commercial production start-up for formulation systems automation and process projects. Amir has been leading different projects during his role at Fresenius Kabi including Building Automation system, Automatic Inspection, Isolator Technologies and Formulation system for Cyto toxic and non-cytotoxic aseptic manufacturing. He holds a Master of Science in Electrical Engineering from Michigan Technological University and joined Fresenius Kabi right after graduation.