Proven Industry Compliance Specialist with a robust background at the Food and Drug Administration/CVM, where I spearheaded the implementation of the eCATS program and managed the center's Export program. Expert in compliance monitoring and project management, I excel in fostering industry awareness and operational support, demonstrating significant achievements in regulatory compliance and technological advancements.
Overview
19
19
years of professional experience
Work History
Industry Compliance Specialist
Food And Drug Administration/CVM
Rockville, MD
09.2005 - Current
Worked in coordination with Consumer Safety Officer to create, implement and approve or reject all of CVM's Drug/Feed Export Certificates.
Helped create and implement our Center's eCATS program in 2020.
Was solely responsible for CVM's Export program from 2018-2019.
Review incoming applications and issue export certificates using the CVM Export Certification Application and Tracking System (CVM eCATS) for all CVM-regulated commodities.
Review incoming applications and issue export certificates using the CVM Export Certification Application and Tracking System (CVM eCATS) for all CVM-regulated commodities.
Monitor export program inbox: cvmexportcertification@fda.hhs.gov.
Answer questions from industry (applicants) and other program-related inquiries.
Keep abreast of legal requirements that affect the export certification program as well as technological improvements and updates to databases such as Online Search and Retrieval System (OSAR), Recall Enterprise System (RES), Center Views (CV), and Compliance Management System (CMS) that interface with CVM eCATS.
Report CVM eCATS errors to FDA’s Unified Registration and Listing System (FURLS) Support Team: furlssupport@fda.hhs.gov.
Identify need for CVM eCATS enhancements and test database enhancements in “preproduction environment” prior to implementation in “production/live environment.”
Submit billing files to the Office of Financial Management (OFM).
Submit metrics reports to management.
Attend the FURLS Quarterly Program Governance Board (PGB) meetings to keep abreast of updates that affect CVM eCATS.
Attend monthly Export Certification Working Group (ECWG) meetings with counterparts from other FDA Centers to discuss issues, updates, and ensure alignment of programs.
Attend monthly Export Certification Working Group (ECWG) meetings with counterparts from other FDA Centers to discuss issues and updates and ensure alignment of programs.
Attend weekly FDA Unified Registration and Listing System (FURLS) Operation and Maintenance (O&M) meetings to discuss database errors and enhancements.
Identify complex issues and request consultation from the relevant subject matter experts (SMEs) in OS&C when complex issues arise during the review of an application.
Notify directors (DDC/DFC) and SMEs of changes/issues that require program-level decision-making.
Skills
Compliance
Industry awareness
Compliance monitoring
Operations support
Documentation review
Project management
Paperless environments
Affiliations
When not at work, I have four children. My oldest is a senior in college, and my other three are in elementary school. We manage a small farm on our property that produces eggs, vegtables, fruit and pork for our family.
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