Maneesha Altekar is a Sr. Technical Manager for Product Robustness & Analytics at AstraZeneca, where she is currently working on the development of a product robustness framework for Operations. Prior to this role, she provided statistical support to the Americas region. She is currently leading an ISPE team to develop a concept paper for PV in packaging. Prior to working at AstraZeneca, Maneesha spent 18 years working in the Chemical industry, providing statistical support for product and process development and optimization. She has presented at various conferences including the ISPE PV & PV Stats conferences, IVT’s Statistics in Validation conference, ASA Joint Statistical Meetings, ASQ Quality Congress, Lab Automation Conference and the Society for Biomolecular Screening, and published several papers. She holds a Ph. D. in Statistics from the University of Delaware.