Over 30 years in the R&D and healthcare industry with expertise in regulatory compliance (Former FDAer) and quality assurance. SME in GCP, GvP, and GLP/GCLP with global regulatory compliance experience auditing against FDA requirements and other standards in support of pharmaceutical and medical device clinical trials such as ICH, ISO, HHS/HIPAA, EU/GDPR and CMS/CLIA. Experience in detecting inherent compliance risks with insights and perspectives working in government, sponsor/Pharma, CRO, sites, service providers (vendors), specialty labs and hospitals. Additional skills in educating and training clinical research professionals through roles with professional associations such as SCRS Ask the Auditor columnist. Ability to perform due diligence assessments on behalf of sponsor organizations therein evaluating not only the sponsor’s Quality Management System (QMS) but each organization’s QMS supporting the clinical trial such as CROs, clinical investigator sites, and vendors to ensure they not only meet regulatory compliance standards but have the infrastructure necessary to successfully execute clinical trial and RWE studies. Key developer in Inspection Readiness Programs with deep understanding “inspection-readiness lifecycle” of a project.
