Principal Consultant
Culmo Compliance Consulting LLC dba CC Consulting, Texas, United States
Cynthia is a licensed pharmacist with 30+ years’ experience across global, FDA and State regulatory enforcement, quality and compliance in manufacturing and distribution, 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 improved quality and compliance as well as successfully addressing Consent Decrees, Warning and Untitled Letters and 483 responses. Additionally, 30+ years’ experience as AFDO’s delegate to the US Pharmacopeia, serving as member of the USP Governance Committee, and several USP expert committees and subcommittees.
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Sunday, June 22, 2025
4:30 PM – 6:00 PM CENTRAL TIME