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Lori Peters is a Consultant in the FDA & Life Sciences practice group. She is a regulatory strategist and scientific advisor with over 20 years of experience in biologics, pharmaceuticals and advanced manufacturing. Lori most recently served as Acting Director of the Division of Manufacturing and Product Quality (DMPQ) at FDA’s Center for Biologics Evaluation and Research (CBER), where she led regulatory oversight of complex biological products and facilities, including COVID-19 vaccines, gene and cell therapies, blood derivatives, tissues and novel diagnostic devices. Prior to her leadership positions, Lori was a Chemistry, Manufacturing, and Controls (CMC) reviewer and lead manufacturing inspector.
Lori is widely recognized for her technical depth, regulatory insight and collaborative leadership across government, industry and legal sectors. Biologics and pharmaceutical manufacturers value her unique insights and experience navigating the FDA review process, regulatory strategy, cGMP compliance risk and manufacturing process development for advanced therapies. Her manufacturing know-how encompasses a breadth of topics including equipment qualification, facility design and validation, cross-contamination prevention, aseptic manufacturing and sterilization methods.
At FDA, Lori managed a division of 65 professionals across six work units, overseeing regulatory decisions for Biologics License Applications (BLAs), Premarket Approvals (PMAs), supplements, and cGMP facility inspections. In 2024 alone, she supervised regulatory activities for 19 BLAs and PMAs, 200+ supplements, and nearly 30 manufacturing site inspections. She ensured product quality and compliance with cGMP regulations under 21 CFR Parts 210, 211, 600, 820, and 1271. As a former lead inspector for the Agency, she has a keen understanding of compliance issues resulting from FDA Form 483 or Warning Letters.
Lori played a pivotal role in FDA’s COVID-19 response, guiding the evaluation and authorization of multiple vaccine manufacturing operations under compressed timelines. She also contributed to the 2024–2028 Strategic Plan and helped develop inspector training programs and performance metrics to strengthen regulatory consistency and staff development.
Before joining FDA, Lori served as an engineer for the Program Manager for Biological Defense at the U.S. Army, where she led test and evaluation programs and quality assurance oversight for a biological agent detection system designed to protect the U.S. military and American public from risk of biological agent terrorist attacks.
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