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Committee & Speaker Biographies

Committee & Speaker Biographies

2019 PDA Practical Applications of Sterile Manufacturing Workshop

March 13-14, 2019, San Diego, CA

  • Shelley Preslar

    Shelley M. Preslar, MBA, PMP

    Azzur Group Raleigh
    Shelley Preslar is a wife, mother, grandmother, business owner and Veteran.  With more than two decades in life sciences, Shelley is General Manager at Azzur Group Raleigh, located in North Carolina, where she leads a team of over 20 specializing in consulting services, business processes, manufacturing, operations and R&D for the country’s top pharmaceutical, biotech and medical device companies.

    Shelley has been a member of PDA for almost 20 years.  She has served on many levels within PDA, including serving as the President of the Southeast Chapter, working with many national event planning committees, assisting with Task Force teams and co-leading technical writing projects.  Shelley leads the PDA Facilities and Engineering IG, whose mission is advancing understanding of existing and cutting-edge facilities and engineering developments internationally by promoting scientifically sound, practical technical information and education for industry and regulatory agencies.

    She has received PMP certification on top of her BS in Marine Biology, graduate studies in Physiology with a minor in Microbiology and a MBA in Global Management. She has served in both the United States Army and United States Marine Corps. 
  • Ana Fonseca

    Ana P. Fonseca

    Novartis

    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

    Amir Zandnia

    Fresenius Kabi USA, LLC

    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.