FDA-CFRs, ISO, OSHA, EPA consultation and waste reduction strategies

Master Control LeadQMS Program ManagementCustomer Complaint ReviewWholesale Drug & 3PL Licenses Distribution Agreement ReviewsQuality Agreement Review and ApprovalSuspect and Illegitimate Product Investigation Quality Assurance Drug Quarantine Release Activities SOPs Remediation [cold chain and logistic operations]Lead CAPA investigation; complaints, non-conformities Regulatory Compliance [FDA 21 CFR Part 11, 205, 210, 211, 820, States BOP, ISO 13485]Customer / FDA / Internal Audit / States BOP / NABP (National Association of Boards of Pharmacy) Audit

•Develop client retention strategies. •Develop HIPAA/HITECH Gap Analysis Tool; ref 45 CFR Parts 160, 162 and 164. •Develop OSHA Gap Analysis Tool; ref OSHA 29 CFR Part 1910 Occupational and Health Standards.

CAPA Remediation/CAPA Auditor

•Facilitated the development of facility & equipment control audit protocols for legacy systems review. •Implemented CAPA Global Legacy Review affecting six United States and twelve EU manufacturing sites.•Implemented audit in accordance to DePuy Synthes Quality Systems Policies, ISO 13485, 21 CFR Part 820

CareFusion, Inc (04/2013)•Achieved operational qualification [OQ], labeling, fluid flow rate testing and visual inspection for Alaris IV Infusion System (450 units). ISO 13485 – Quality Systems Management Unival, Inc. (2004 – 2007)•Performed 25 plus clinical sites audits per sub-parts of TJC (JCAHO), HIPAA 45 CFR Parts 160 and 164, and OSHA 29 CFR Part 1910.Genesis Marketing, LLC (2002 – 2003)•Developed HIPAA Gap Analysis Tool per 45 CFR Parts 160, 162 and 164.

Business Development

•Managed facility equipment operational requirements.•Implemented donor medical record audit criteria and sampling plan per MIL Standard 105D.•Reviewed suppliers’ quality requirements for cleaning, disinfection and sterilization supplies.•Performed safety, quality, compliance training, and quality metric reporting; ref ISO 13485 and OSHA 29 CFR Part 1910.•Created irradiated ocular tissue technical files; ref MDD 93/42/EEC for State of Israel Ministry of Health & South Korea Ministry of Health and Welfare.•Authored and maintained tissue banking SOPs, CAPA, MedWatch FDA Adverse Event Reporting/21 CFR Part 803 Medical Device Reporting/FDA 21 CFR Part 820/ISO 13485.•Performed and influenced 21 CFR 1271 HCT/P, EBAA Medical STD (tissue banking accreditation), OSHA 29 CFR Part 1910, FDA 21 CFR Part 820 and HIPAA 45 CFR Parts 160 & 164 auditing and remediation activities/outcomes. •Prepared FDA export certifications for ocular tissue exports to several foreign countries (Greece, Iraq, Israel, Japan Jordan, Korea, Morocco, Oman, Pakistan, Palestine, Saudi Arabia, Syria, Tunis, UAE, Yemen, Germany & Russia).•Project Leader; qualification/validation IQ/OQ/PQ (21 CFR Part 11 Electronic Records; Electronic Signatures, ISO 13485) - medical equipment, environmental monitoring system, sterilization equipment, refrigeration/sub-zero freezers, laser microscope, MS SharePoint and labeling bar coding.•Performed, where applicable – ocular tissue distribution network, annual registration requirements with States’ Department of “Health Services” including FDA and Health Canada-CTO.

•Managed HazMat waste disposal process per 40 CFR - Protection of Environment. •Utilized root cause analysis for incident investigations; ref 21 CFR Part 820 and FDA Guidelines for CAPA investigations.•Established and chaired Safety, Emergency Management, Medical/First Aid, and Safety committees; ref 29 CFR 1910.

•Trained employees on safety regulation.•Achieved 1,000,000 hours worked w/o lost time incidents.•Resolved investigation incidents utilizing FDA CAPA guidelines.•Achieved incident severity rate (1.3%) below industry standard of 7%. •Developed PPE inventory, assignment, and inspection tracking system.•Maintained incident report statistics and safety data monthly scorecards. •Hosted 3rd Party Gallagher Bassett Services, Inc. OSHA 29 CFR 1910 compliance audit.•Established and chaired Chair Safety Committee – developed awareness initiatives and address compliance issues. •Authored facility safety, health emergency evacuation and operation manager’s incident investigation policies/procedures to comply with ISO 14001 Environmental Management System, NFPA, and OSHA 29 CFR 1910.

The Greater Memphis Association for Quality is a nonprofit organization that promotes quality systems and performance/process excellence utilizing the Malcolm Baldrige National Quality Program Criteria for Performance Excellence. As a Quality Examiner, Quality Examiner examines/auditor healthcare organizations processes and documentation to determine compliant against Criteria for Performance Excellence.

• Executed ANSI GDT y14.5 into SOPs.• Executed task requirements to address CAPA.• Executed requirements/applied 510K, 21 CFR Part 11 and 820, ISO 9001 and 13485 (guidance document). • Participated/influenced FDA and ISO QMS audits outcomes achieving zero [0] deficiencies. • Initiated “Medical Device Quality Procedure” process improvement initiative – est. saving $245,000.• Performed validation (21 CFR Part 11 - IQ, OQ, PQ) for PLM system (automate device master records).• Authored/executed global risk assessment tool for DMR/DHF device change and inventory management. • Integrated online computer system (COPICS) into Product Development and Regulatory Compliance.• Developed project management dependencies/interdependence criterion for new medical devices. • Assisted in assimilation of NB/CE marking, technical files/product dossier (MDD), 510k, PMA, and IDE requirements.• Project Lead - medical device master records automation project (PLM) - $ 3.5 million capital investment. • Executed process improvement (CAPA investigations/FMEA/PMEA); DMR/DHF, device master record change process - improved cycle time (30 days to 2 days).• Executed remediation action - FDA 483 warning letter (NeoMed – Defibrillator Manufacturer). • Authored/executed SOPs and training programs for product computer data master entries, computer validation, device master records; ref 21 CFR Part 11 and 820, ISO 9001 and 13485. • Created/executed engineering change/configuration management policies/procedures per 21 CFR Part 820.• Created/executed quality system to comply w/21 CFR Part 820, ANSI GDT y14.5, ASTM, and ASQ.• Managed technical personnel; DMR/DHF processing (product, manufacturing, quality specification, change management/document control, quality data entry), purchasing and inspection.• Coordinated/reviewed vendors/suppliers’ quality requirements for tooling, raw materials, semi-finished and finished goods, including specification interpretation and acceptance criteria.