Ahead of a regulatory inspection, customer audit, or due-diligence review, I conduct on-site gap assessments and GMP/vendor audits, and help draft your response when findings need to be addressed — including direct experience responding to FDA Form 483 observations and deficiency letters.
I have audited most of the internal operations I was responsible for, plus more than 21 outside laboratory services, contract manufacturing facilities, and manufacturing facilities for cGMP compliance, reporting the compliance gaps in official audit reports. I have also developed audit programs covering internal, external supplier quality, and contract laboratory services.
I have supported site leads through governmental inspections, including FDA, DEA, and other governing bodies, and responded to FDA Form 483 observations, deficiency letters, and inquiries.
I took part in pre-approval inspections, facing FDA and EU regulatory bodies, and provided support and responses to regulatory agencies during pre-approval inspections and after launch.
I co-audited contract manufacturing sites, worked with site management on audit reports and remediation planning, followed up on audit responses, and monitored quality trends as sites implemented their quality systems.
Walk into an inspection or audit knowing where you stand — and what's already fixed.