Compliance with FDA CGMP, EPA, ICH, ISO, and other quality standards pertinent to the pharmaceutical, medical device, biologics, consumer product, and environmental industries.
ASQ Certified Quality Auditor
Extensive experience in developing, re-engineering, and auditing quality systems for quality control laboratories to ensure compliance with a variety of international standards. Has participated in more than 10 FDA inspections, both domestic and international. Hosts FDA, regulatory, accreditation body, and client audits and prepares responses and quality improvement plans to address findings. Provides quality system training and FDA regulatory guidance to both employees and clients.
Created the NCR/CAPA, OOS investigation, document control, materials control, internal audit, and instrument qualification programs for the Santa Fe Springs Health Sciences laboratory. Developed the guidelines for an extensive 21CFR Part 11 software remediation project for the Health Science laboratories. Achieved ISO/IEC 17025 accreditation for the laboratory through A2LA.