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) (Invited) will be attending:
FDA Investigator Insights
Setting the Foundation for Inspection Readiness
FDA and MHRA Investigator Insights
Supplier Partnership Systems that Work
Operationalizing Effective Integrated Supply Chains
FDA, MHRA, and Fimea Inspection Trends and Expectations