Erica Agy has more than 20 years of experience in Quality Assurance. As the Senior Manager of Quality Assurance, I am responsible for the regulatory and accreditation continuous readiness program managing inspection preparation, coordination, performance and follow-up for FDA, FACT, CAP, TJC, and clinical trial sponsor audits and monitor visits for both the Cellular Therapy Laboratory and the Apheresis Unit at Fred Hutchinson Cancer Center. I am a practiced auditor to both internal and regulatory standards and routinely work with multiple organizations to ensure a safe and efficient process for delivering life-saving products.