Kathleen Culver (Co-Chair)

Kathleen Culver (Co-Chair)

Field Investigator and Drug Pre-Approval Manager, FDA , Cincinnati District

Kathleen has been with FDA for 20 years as a Chemist in the Southeast Regional Laboratory, an Investigator in Atlanta District and an Investigator and Drug Preapproval Manager in Cincinnati District. She has conducted numerous GMP and drug preapproval inspections. In her current position, she conducts GMP and preapproval inspections, provides technical and case development guidance to other FDA investigators and manages the Cincinnati district’s drug preapproval program. She received a B.S. in Chemistry from Eastern Kentucky University.

Events Kathleen Culver (Co-Chair) will be attending:

  • PharmaLink 2016

  • FDA Investigator Insights

  • Setting the Foundation for Inspection Readiness

  • PharmaLink 2015

  • FDA and MHRA Investigator Insights

  • Supplier Partnership Systems that Work

  • Operationalizing Effective Integrated Supply Chains

  • PharmaLink 2013

  • PharmaLink 2014

  • FDA, MHRA, and Fimea Inspection Trends and Expectations