Microrite Inc

GMP consulting and training covers practical facility, cleanroom, validation, microbiology, quality assurance, and analytical quality control needs for pharmaceutical, biotechnology, and medical device organizations. Services include basis of design reviews, airflow visualization, cleanroom contamination troubleshooting, validation work, and disinfectant qualification. The company also develops contamination control strategies and risk-based environmental monitoring programs, and supports aseptic process simulations, media fill investigations, and sterilization consulting. Quality services include mock FDA inspections, inspection readiness, FDA 483 response and remediation, and CSV and data integrity audits. Training is available through webinars, workshops, and onsite sessions. Specialties include cleanroom airflow and contamination control, along with risk-based GMP consulting. Based in San Jose.