President & Founder — Former FDA Investigator
Dusty Snoeberg-Renwick
Former FDA pharmaceutical and medical device investigator who founded the firm in 2004 to build quality systems people can actually follow.
- Quality Systems
- Process Validation
- cGMP
- QMSR
- Consent Decree
30+ years FDA and industry
Background
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.
She founded xFDA Investigators, LLC in 2004 on a simple conviction: federal cGMP, QMSR and GCP requirements are not hard to meet when the right procedures and systems are in place. Most compliance trouble begins with well-intentioned procedures that nobody on the floor can follow.
What Dusty does on an engagement
- Quality system design, assessment and remediation
- Process validation strategy and execution
- FD-483, Warning Letter and Consent Decree response
- Pre-approval and cGMP inspection preparation
- Executive-level regulatory advisory and FDA interaction
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Describe the product, the process or the problem. We will tell you honestly whether we are the right people to help, and who should be on the team if we are.