Principal & COO
Julie Larsen is a principal consultant and director of inspection readiness services at BioTeknica, Inc., a quality and regulatory compliance and engineering consulting firm in Coral Gables, Florida. She is a certified quality manager (CQM), a medical technologist (MTASCP) and has more than 25 years’ experience in quality assurance and compliance in the medical device and pharmaceutical industries. Ms. Larsen has extensive experience in quality systems remediation for compliance improvement and constructing responses and corrective action plans for consent decree, warning letter and form 483 responses as well as development of quality systems.
Welcome Back from COVID: Preparing for and Managing an FDA Inspection