Azita Nejad is an independent Consultant at in3 GMP Consulting with over 25 years of experience in QA and QC. Azita’s extensive global experience spans in the wide range of Quality Assurance/Compliance, Quality Control, Validation (method, process, and computerized systems), GMP Inspection Readiness, and CMC Regulatory Affairs. She is highly specialized in phase appropriate quality management for solid oral dosage, sterile, and inhalation products as well as active pharmaceutical ingredients. She has in-depth knowledge of US and international regulations and is skilled in preparation and readiness for US and EU inspections. Nejad has held senior management positions in integrated manufacturing and virtual companies. Her last position was at Gilead Sciences as Senior Director, Quality where she managed clinical products quality (IND to launch), quality systems, and pharmaceutical and development manufacturing informatics.