Over 40 years experience in Medical Device, Dietary Supplement, and Pharmaceutical Manufacturing, QA, GXP Auditing and Compliance. I have managed over 200 FDA and International MOH Inspections primarily in the US and Europe.
Specialties: GXP Auditing (GMP Auditing, GLP Auditing, GCP Auditing, Pharmacovigilance Auditing), GXP Gap Analyses, Supplier and Contract Manufacturing Auditing, Regulatory Agency Inspection Management, CAPA Project Leadership, GXP Compliance Consultation, SOP and Documentation System Development, Aseptic Processing, 21 CFR Part 11 Electronic Records and Signatures, and Greenfield Analyses
Responses and remediation for FDA 483 Observations, Warning Letter Observatio...
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