Thank you for your interest in xFDA Investigators. I would like to tell you, briefly, why this firm exists and how we prefer to work.
I began my career as an investigator with the U.S. Food and Drug Administration, conducting pre-approval and cGMP inspections of pharmaceutical manufacturers, inspections of medical device operations, and inspections in the clinical research setting. Over those years I walked through a great many facilities, reviewed a great many quality systems, and spoke with a great many people who were genuinely trying to do the right thing.
What struck me then, and still does, is how often difficulty came from the same place. Not indifference. Not a lack of effort. Companies that were working extremely hard were nonetheless struggling, because the systems they had built asked more of them than the regulations ever did.
Complexity is not the same thing as compliance
Regulatory systems should be compliant and robust. They should not be unnecessarily complicated. When a procedure requires four signatures where one decision is needed, or commits the organization to a timeline it has never met, that procedure has created a new source of deviations. Every one of those deviations consumes the time of the very people who should be preventing the next problem.
I have watched organizations spend enormous resources maintaining requirements they imposed on themselves, believing FDA required them. Frequently, FDA did not.
Why I established xFDA Investigators
I founded this firm in 2004 to help companies see that difference clearly — to understand what regulators actually expect, and to build systems that meet those expectations while remaining practical for the people who have to use them every day.
Our objective in every engagement is a quality system your employees can understand, implement and sustain after we are gone. If a system only functions while consultants are on site, we have not done our job.
Who we bring with us
Over the years I have built a network of former FDA investigators, former compliance officers, quality executives, validation specialists, manufacturing and laboratory professionals, and clinical quality experts. We assemble teams around the specific needs of each project, because the right person for a sterile fill-finish question is rarely the right person for a data integrity remediation.
An invitation
If you are facing a compliance challenge, preparing for a significant change, standing up a quality system for the first time, or simply unsure whether what you have is adequate — call and describe it. I will tell you honestly what I think, including when the answer is that you do not need us.
Dusty Snoeberg-Renwick
Founder & President
Former FDA Pharmaceutical & Medical Device Investigator