FDA Compliance Consultant with over 25 years combined consulting, FDA, and industry experience. Consultant to FDA regulated industry since 2002. Perform Mock Pre-Approval Inspections, cGMP Audits, and Due Diligence Assessments of international and domestic manufacturers and laboratories with identification of significant deficiencies and recommendations for remediation. Advise Regulated Industry Executives on critical compliance deficiencies, risk mitigation strategies, remediation plans, and FDA expectations. Assist in guiding and developing Corrective Action Plans, formal responses and correspondence with FDA, and procedures that comply with FDA expectations. Develop and provide customized training on various topics to meet the individual needs of each client, including FDA Pre-Approval Inspection Readiness and Annual cGMP Training. Manage and coordinate consulting projects to assure the quality work products and timely completion of requested services. Former FDA Chemist and FDA Investigator for the Atlanta District Drug Cadre. In both roles, conducted numerous cGMP and NDA/ANDA Pre-Approval Inspections at major pharmaceutical facilities, including compliance audits of Active Pharmaceutical Ingredients and major dosage forms. As the Acting NDA/ANDA Pre-Approval Manager for the Atlanta District Office, facilitated high priority Pre-Approval assignments, performed technical review of applications, and provided assessment of pending NDAs/ANDAs. Prepared industry seminars, meetings, and conferences addressing regulatory compliance issues and addressed pharmaceutical executive management on topics of mutual concern. Trained other FDA Investigators, Analysts, and Regional employees in the procedures and methods of evaluating compliance during drug inspections to ensure consistency with Agency policy.Specialties: Assessment of sterile and non-sterile pharmaceutical dosage forms and Active Pharmaceutical Ingredients (APIs), quality systems, facilities, containment, bioburden control, environmental monitoring, chemistry and microbiology laboratories, data integrity, stability programs, validation and qualification, materials management, packaging, labeling, and REMS compliance