Stephanie White

Stephanie White is a pharmaceutical and biotechnology manufacturing leader with more than 24 years of global and site-based experience in operational readiness, commissioning, qualification, and validation, computerized system validation, quality risk management, and computer software assurance. She is Founder and Owner of DayOne Pharma Consultants and has held leadership and technical roles with A-Bio, Emergent BioSolutions, Takeda Plasma Operations, Amgen, Baxter International, Pfizer, and CRB. Her work focuses on helping project teams deliver qualified, inspection-ready facilities, utilities, equipment, and computerized systems through practical, science- and risk-based approaches. Stephanie is an active ISPE contributor and recognized thought leader, serving as Chair of the ISPE Commissioning & Qualification Steering Community of Practice and as a member-at-large of the ISPE Digital Validation Sub-Committee. She has contributed to ISPE guidance documents, including Good Engineering Practice and Digital Validation, presented ISPE webinars, and co-authored articles for Pharmaceutical Engineering Magazine. Stephanie holds master’s degrees in Engineering Management and Biomedical Quality Systems, as well as bachelor’s degrees in Electrical Engineering and Education.