This education event will begin with an hour of networking with food and drinks, after which the event will transition to an educational focus. Julia O’Neill, an expert in the pharmaceutical application of statistics, will provide Part 2 of her well-received presentation on Statistics in CMC. Julia has given this presentation to the FDA to train them on pharmaceutical statistics and their applications. This portion will cover managing process and assay changes, special challenges for vaccines and biologics, significance and equivalence, assay and reference standards issues, and evaluating assay and process contributions to variation.
Julie is a global pharmaceutical leader with over 30 years of data science and process analytics experience in the vaccines, biologics, pharmaceutical and chemical industries. Her technical expertise spans research and development, manufacturing, corporate and direct customer support functions. She has a proven record of consistently building and leading technical teams to creative positive change and deliver transformational results.
Prior to joining Tunnell, Julia was Director of Engineering, Global Technical Operations at Merck and Co. where she was responsible for development and deployment of process robustness strategy for manufacturing. Her team designed and deployed Continued Process Verification for vaccines and biologics, and supported CPV for hall human health products. Previous positions include Senior Scientific Fellow - Statistics in Regulatory and Analytical Sciences at Merck; Director, Engineering Vaccines and Biologics Technical Operations at Merck; and Powder Coatings Process Development Leader at Rohm and Haas Co. Julia is a Master Black Belt and expert in resolving challenging problems using statistical, engineering and Six Sigma methods. She holds a BS in Chemical Engineering from University of Maine and MS in Statistics from University of Wisconsin.
|ISPE Young Professionals||$35|