FDA Warning Letter Review and the Tie to Audit Compliance
Program: Applied Biotechnology Master's Degree — Quality Assurance and Compliance
Host Company: Regeneron Pharmaceuticals
Location: Rensselaer, New York (hybrid)
Student: Megan Schubmehl
This capstone project reviewed multiple executions of Form 483 to identify trends based on the letters to aid companies in developing strategies to ensure FDA compliance and reducing losses.