Inspectional Readiness


Inspectional Readiness:
Are Your SMEs Prepared
for A Successful FDA Visit?

Your office, June 12, 2014


Meet your instructors

Julie Larsen, Principal/Director, Inspection Readiness Services for BioTeknica, has more than 20 years’ 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 Letter and 483 responses.

Arnold Solomon is the President of FDA Strategic Compliances, LLC. For over ten years, Mr. Solomon was the Vice President Divisional Quality and Compliance at Roche Diagnostic. He has over 30 years of experience working as a quality manger. Prior to working at Roche, Mr. Solomon was a former FDA investigator and supervisory investigator.