Do you feel your company is ready for its next FDA inspection❓Are you up to date on the latest regulations & standards❓​Do you have the right people capable of responding to FDA inspection observations or warning letters❓Do you struggle to systematically address recurring product quality issues❓Are your quality processes well-established, lean and practical or are they overly burdensome❓Do you have the right people to ensure compliance with US and international regulatory requirements❓⭐️ With over three decades of industry experience including former FDA Investigator, the experts at CREO Consulting and I help prepare organizations across the spectrum—from startups to fully commercial enterprises—for regulatory scrutiny. ⭐️⭐️ Inspection Readiness & Support​ ⭐️• Mock FDA inspections​• Design documentation reviews​• Mfg. facility assessments​• Interviewing skill assessments​• Inspection management​• Mock recalls​• Routine internal audit programs​• Risk management programs​• Regulatory information systems​• Supplier / supply chain readiness assessments• Routine supplier audit programs⭐️ Regulatory Responses & Remediation​ ⭐️• FDA-483 responses​• Warning Letter responses​• Corrective action planning​• Project management​• Ongoing quality remediation support​• Inspection “post-mortems”​• Risk assessments​• Risk mitigations⭐️ Root Cause Investigations​ ⭐️• Identification of true root cause• Creating action plans to address and eliminate recurring issues​• Validation strategy assessments​• Validation protocol development​• Validation execution and testing​• Root cause investigation training⭐️ Process Benchmarking & Optimization​ ⭐️• Application of lean principles across all quality and operations processes• Quality process creation / scale-up​• Process monitoring and continuous improvement programs​⭐️ People & Organizational Evaluation ⭐️ ​• Behavioral observations and organizational structure evaluations​• Comparisons against industry best practices​• Management review assessments​• Fractional Quality leadership roles​• Mentoring of high-potentialsAreas of Expertise:FDA Regulations / QSR / QMSRISO 13485 Quality Management SystemsFDA Inspection ProceduresQuality System Inspection Technique (QSIT)Quality AssuranceRegulatory ComplianceChange ControlFDA Readiness and RemediationRecall / Field ActionComplaint HandlingInternal, Supplier, Third Party AuditsCorrective ActionPreventive ActionQualification and ValidationDesign ControlManagement ReviewClinical TrialsSterilizationExpert Witness