FDA RESUME - Unknown Company
This document outlines the professional experience and objectives of Michelle Webb, a Consumer Safety Officer/Investigator at the Food and Drug Administration (FDA) since June 2015. The document does not provide specific inspection dates or detail particular violations/issues, but it highlights Webb's role in conducting regulatory operations, including domestic and international inspections, recall audit checks, sample collections, and investigations for food and feed firms under FDA jurisdiction.
Webb's responsibilities involve ensuring compliance with federal regulations, providing inspectional coverage for complex issues, and applying risk management principles. She is tasked with documenting and maintaining regulatory notes in line with agency procedures and policies, advising firms of apparent violations, and ensuring timely documentation and action on reports, findings, and violations in accordance with FDA guidelines.
The regulatory framework under which Webb operates includes the Investigations Operations Manual (IOM), Regional/District Standard Operating Procedures (SOPs), and the Quality Management System. Her work supports the Office of Regulatory Affairs' (ORA) mission and goals.
Required actions for Webb include managing work plans, preparing for investigational activities, ensuring equipment functionality, evaluating processes and systems, and responding to public inquiries about regulations. She is expected to maintain technical competency, demonstrate knowledge of FDA regulations, and actively participate in quality improvements and performance evaluations. Webb's role is crucial in ensuring public safety and compliance within FDA-regulated industries.
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