Conduct complex domestic and international inspections and investigations of FDA's Bioresearch Monitoring Program to ensure the protection of the rights, safety, and welfare of human and animal subjects involved in FDA-regulated studies.

Conduct domestic and international inspections and investigations of FDA's Bioresearch Monitoring Program to ensure the protection of the rights, safety, and welfare of human and animal subjects involved in FDA-regulated studies. Conduct PADE, REMS, BEQ, GLP and BIMO inspections of all types to verify the accuracy and reliability of clinical study data submitted to FDA in support of research or marketing applications. Investigate complaints related to investigator conduct, patient safety and data integrity in clinical studies and work with all six of the FDA Centers and OCI. Loving the Southern Hospitality and the warm Atlantic Ocean and the beautiful Cooper River running along side my home !

• Conduct cGMP Gap Analysis Assessments;• Conduct due diligence audits; • Conduct simulated mock FDA drug and device inspections; Review CAPA, complaints, MDRs, validations for compliance;• Prepare audit plans;• Prepare audit reports;• Full Supplier-Vendor qualifications and audits; Internal audit compliance;• Review procedures, FDA 483s, and prepare warning letter responses;• Quality System review and compliance with ISO, CFR820 and CMDR.• Biological monitoring of clinical investigators and sponsor/monitors; • Review protocols, CRFs, and GCPs for compliance;• Write reports and determine compliance with Protocols and GCPs;• Troubleshoot technical issues and interpret compliance problems.

• Lead Investigator on complex and high-risk domestic and international drug and medical device Inspections;• As Lead Investigator set objectives, organized, planned, coordinated, assigned and reviewed work of other professional staff;• Reviewed complex medical device and pharmaceutical cases and prepared reports of significant deviations to FDA laws and regulations;• Assigned complex enforcement cases and investigations to evaluate and recommend enforcement actions; • Interfaced with FDA Headquarters in the assessment of special investigations and complex cases;• Interfaced with industry during compliance meetings, inspections and inquiries;• Prepared detailed narrative reports of findings, prepared exhibits and photographs;• Conducted investigations of complaints involving serious injuries and prepared Investigative Memos;• Biological monitoring of Clinical Investigators and sponsor/monitors. • Interfaced with various Centers for assignments of Clinical Investigators (CI) and sponsor/monitor sites;• Determined compliance with Protocols and informed consent; • Reviewed CRFs, reports and case files to ensure GCP and compliance;• Prepared reports of findings for sponsors and CI sites for Center review;• Conducted international inspections for both drugs and devices in Belgium, UK, Germany, Canada, Portugal, Italy, Switzerland and Wales.

Supervised and implemented Environmental Health Services Programs for the County of Orange, CA;Supervised Hazardous Materials Staff in conducting inspections, investigations, and complaints involving hazardous waste, underground storage tanks, medical waste, and soil contaminated sites requiring remediation; Reviewed employee Inspection Reports and supervised staff in complex inspections and investigations;Trained new and existing staff in the hazardous waste, underground storage tank and medical waste laws and regulations, and safety and environmental health issues;Developed policies and procedures related to Hazardous Waste and Underground Storage Tank inspections and enforcement activities;Member of the County’s Emergency Response Team - responded to chemical spills and illicit drug lab operations, oversaw cleanup operations, secured emergency response funding for cleanup operations and analyzed chemicals for characterization and disposal;Worked with local and state officials and enforcement agencies to secure sites, coordinate activities, information sharing and cleanup operations;Work with local fire departments to ensure safe environments and make recommendations;40-Hour OSHA Trained in Level A responses to emergency incidences;Prepared Emergency Response policies and procedures;Prepared Investigative Memos of findings with exhibits and documented evidence for legal action;Worked with the County’s District Attorney’s office in the preparation and enforcement of cases against violators of the laws;Backup to the County’s Industrial Hygienist in responding to employee exposure complaints;Developed Health and Safety policies and procedures and oversaw implementation for employee safety;Analyzed Legislation related to Hazardous Waste, Medical Waste and Underground Storage Tank Laws and Regulations for impact to the County’s public health and environmental health programs