Cynthia T. Culmo

Cynthia is a licensed pharmacist with 25+ years experience across global, FDA and State regulatory enforcement, quality and compliance in manufacturing and distribution with pharmacy, enforcement and industry management and leadership roles in medical products, including medical devices, biologics, and pharmaceuticals. She has extensive experience with strategy, coordination, and management of FDA, global agencies and Notified Third Body inspections, remediation of quality systems for compliance improvement as well as successfully addressing Consent Decrees, Warning and Untitled Letters and 483 responses. Additionally, 20+ years experience as an US Pharmacopeia volunteer, serving as member of the USP Governance Committee, and several USP expert committees and subcommittees.