James Stumpff

Background

About James Stumpff

I am a former FDA manager with over 30 years of regulatory and compliance experience in medical devices and biopharmaceuticals. SUMMARY OF EXPERIENCE: A regulatory professional with over 30 years of experience including over 23 years of Food and Drug experience primarily in the regulation of biologics, medical devices and pharmaceuticals. Key skills include: • Data integrity assessments and remediation including FDA Application Integrity Policy • Mock Pre-Approval inspections and remediation of gaps in biopharmaceutical and medical device facilities • Gap Analysis of Quality Systems and remediation • Consent decree audits and remediation in both pharmaceutical and medical device facilities • Assist clients with FDA-483 & Warning Letter responses and remediation of regulatory issues • Provide backroom support & preparation of SMEs as well as inspection management strategies during regulatory authority inspections • Assist clients with CRO preparation for FDA GXP inspections • Provide a variety of interactive training including management of regulatory inspections, responsibilities of the Quality unit and GMPs, GCPs, and QSRs • FDA Regulatory Actions, Form FDA 483 and Warning Letter responses and updates • Good Manufacturing Practice and Biologics Regulations • Quality System Regulations • Medical Device Reporting including drafting, review, and approval of events • Combination Product Regulations • Preapproval/Pre-license Inspections • Good Laboratory Practice Regulations • Good Clinical Practice Regulations • Abbreviated New Drug Applications and New Drug Applications • Pharmacovigilance Regulations including review, approval and reporting of adverse events • Investigational Device Exemption (IDE), 510(k) and Pre-market Approval (PMA) Applications • Audits/Gap Assessments and Remediation of Medical Device, Biologics and Pharmaceutical Facilities • Project Management and Personnel Supervision in a remote environment • Regulatory Affairs assist in drafting, and review and approve submissions