Led by the people who still do the work

Dusty Snoeberg-Renwick has more than 30 years of combined FDA and industry experience in the interpretation and implementation of FDA regulatory requirements. Her work spans pharmaceuticals (GMP), medical devices (QMSR) and biotechnology (BIMO) — implementing quality systems that hold, and working alongside executive management and the Agency to resolve FD-483, Warning Letter and Consent Decree issues.

While serving as an FDA Investigator she was regarded as an expert in process validation and GMP compliance. In industry she helped extricate the first medical device firm ever placed under a Consent Decree. She knows how to assess a quality system quickly and how to implement one that is compliant without becoming impossible to execute.

Shane Snoeberger is a quality assurance and operations expert with more than 20 years of combined experience in FDA- and DEA-regulated industries. He is a certified quality engineer (CQE) and a Lean Six Sigma Black Belt, and serves as Vice President of xFDA Investigators, LLC as well as Business Management Services Director.

He served in the United States Marine Corps, managing QA/QE for aviation electronics and validation systems at Air Station Miramar in San Diego, assuring compliance with applicable government standards. In industry he has worked with pharmaceutical and medical device manufacturers as VP of Quality, Director of Operations, Quality Engineer (SME) and QA/Compliance Manager, and as a compliance consultant on quality systems, remediation programs and due diligence audits.