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Auditing and Gap Assessments

01:16:00

Mar 8, 2019 12:34 PM Eastern Time (US and Canada)

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Speakers

Erica Fadool
Manager of Compliance @Kymanox
Erica Fadool is the Manager of Compliance and Auditing at Kymanox. Erica has expertise in Quality Management Systems, Quality Control (QC), Analytical Method Validation and Transfer, Equipment Qualification, Six Sigma/Kata, Aseptic Process Simulation, Process Performance Qualification, Technology and Process Transfer, Commercial Startup, and Auditing. During her career, Erica has directly supported Food and Drug Administration (FDA) Pre-Approval Inspections (PAIs), bi-annual inspections, and Biologics License Application (BLA) submissions to FDA and the European Medicines Agency (EMA). She has performed Mock Pre- Approval Inspections for Medical Device and Small Molecule Drug manufacturers to ensure licensure approval by regulatory agencies. Erica has a Bachelor of Science Degree in Chemistry from North Carolina State University. She is a Certified Quality Auditor (CQA) through the American Society for Quality (ASQ) and is a certified Six Sigma Green Belt.