Derek Wessman

Regulatory Inspection, Audit, Project Experience

US FDA Medical Device Inspections: 〜100 (Routine, PMA, Warning Letter Closure, others)

US FDA Drug Product Inspections: 〜30 (Routine, NDA, Warning Letter Closure, others)

US FDA Combination Product Inspections: 〜15 (Routine, Approval; Both Drug and Device focus)

Brazil ANVISA Medical Device Inspections: 〜10 (Routine, Approval-related)

US FDA Warning Letter Remediation Projects: 〜5 (Medical device-related)

Other Full-QMS Remediation Projects: 〜5 (Medical device-related)

WHO-PQ Inspections: 〜5 (Approval-related)

EU EMA Drug Inspections: 〜5 (Routine, Approval-related)

Korea KFDA Medical Device Inspections: 〜5 (Routine, Approval-related)

ISO 13485, ISO 9001, Other-standard Audits: 〜25 (Primarily supplier audits)

US FDA 510(k) Applications: 〜10

US FDA 513(g), Pre-sub Consultations: 〜10

Japan PMDA, US FDA GCP Inspections: 〜10 (Approval-related)

Sampling of Specific Regulatory Inspection, Audit Experience

Medical Device / IVD

Blood Pressure Monitor FDA Routine Inspection (Multiple)

Fecal Occult Blood Test Instrument / Reagent Factory FDA Routine Inspection (Multiple)

Fecal Occult Blood Test Instrument / Reagent Factory Brazil ANVISA Inspection

Fecal Occult Blood Test Instrument / Reagent Factory WHO Pre-Qualification (PQ) Inspection

Medical Imaging Device Factory FDA Routine Inspection (Multiple)

Injection-molded Syringe Factory FDA Routine Inspection (Multiple)

Gamma-sterilized Syringe Factory FDA Routine Inspection (Multiple)

Catheter Factory FDA Routine Inspection (Multiple)

Blood Bag Factory FDA Routine Inspection (Multiple)

Infusion Set Factory FDA Routine Inspection (Multiple)

Lower Peripheral Stent Factory FDA Routine Inspection (Multiple)

Coronary Stent Factory FDA Routine Inspection (Multiple)

EtO-sterilized Lower Peripheral Stent Factory FDA Routine Inspection (Multiple)

EtO-sterilized Coronary Stent Factory FDA Routine Inspection (Multiple)

Drug-eluting Stent (DES) Factory FDA Routine Inspection (Multiple)

Influenza Test Kit Factory FDA Routine Inspection (Multiple)

Influenza Test Kit Factory WHO-PQ Inspection

PCR Reagent Bottle Injection Molding Factory FDA Routine Inspection (Multiple)

PCR Analysis Instrument Factory FDA Routine Inspection (Multiple)

PCR Reagent Factory FDA Routine Inspection (Multiple)

Injection Needle Factory FDA Routine Inspection (Multiple)

EtO-sterilized Injection Needle Factory FDA Routine Inspection (Multiple)

Coronary Stent Trial Site GCP FDA Approval Inspection (Multiple)

Blood Filtration Fiber Product Factory FDA Routine Inspection (Multiple)

Oxygenator Factory FDA Routine Inspection (Multiple)

Fundus Camera Factory FDA Routine Inspection (Multiple)

Opthamological Slit Lamp Factory FDA Routine Inspection (Multiple)

DNA / RNA Analysis Reagent (Multi-assay) Factory FDA Routine Inspection (Multiple)

Medical Imaging Monitor Factory FDA Routine Inspection (Multiple)

Supplier Audits on behalf of IVD manufacturer (Multiple)

Combination Products

Prefilled Syringe (Biologic) Aseptic Filling Combination Product FDA Pre-approval Inspection (PAI) (Multiple)

Prefilled Syringe (Biologic) Aseptic Filling Combination Product FDA Routine Inspection (Multiple)

Lidocaine Patch Combination Product Factory FDA Mock Inspection (Multiple)

Lidocaine Patch Combination Product Factory FDA Pre-approval Inspection (PAI)

Drug Products

Aseptically Filled Injectable Drug Factory FDA Pre-approval Inspection (PAI) (Multiple)

Aseptically Filled Injectable Drug Factory EU EMA Pre-approval Inspection (PAI) (Multiple)

Oncolytic Virus for Malignant Glioma Factory FDA Pre-approval Inspection (PAI) (Multiple)

Intestinal Regulator Drug Product Factory FDA Routine Inspection (Multiple)

Cold Medicine Tablet Factory FDA Routine Inspection (Multiple)

Anticancer Drug Factory FDA Routine Inspection (Multiple)

Anticancer Drug Factory EU EMA Inspection (Multiple)

API Supplier Audit on Behalf of Biological Drug Manufacturer (Multiple)

API Supplier Audit on Behalf of Eye Wash Manufacturer (Multiple)

API Supplier Audit on Behalf of Antidepressant Manufacturer (Multiple)

Supplier Evaluation Support for Oncolytic Virus for Malignant Glioma

Other Experience

・Published Definitive FDA 21 CFR Part 820（QSR）English-Japanese Translation

・Issued Definitive FDA QMSR English-Japanese Translation

・FDA QSR-related Seminar Instructor