Julie Larsen is principal and director of inspection readiness services and COO at Bioteknica, an IQVIA company. Julie has more than 20 years of experience with quality assurance and compliance in manufacturing, division, and corporate roles in medical device and pharmaceutical industries (17 years leadership experience in quality operations and compliance). She has extensive experience with strategy, coordination, and management of FDA inspections, remediation of quality systems for compliance improvement, as well as successfully addressing consent decree, warning letters, and 483 responses.