Extensive FDA compliance & policy experience in foods, drugs, devices, dietary supplements and veterinary products.GMP Audits, Due Diligence, Labeling, Imports, Standards, Quality Systems, Laboratory Accreditation.

Audit combination products

FDA, Office of the Commissioner, Rockville, MD Office of International Programs International Affairs Policy Analyst, North American Desk, 2003 -2006Project manager to coordinate and exchange information with foreign governments territories covering Canada, Mexico, Caribbean and Latin American countries pertinent to trade. Provided a communication conduit, discretionary disclosure (21 CFR Part 20), to allow for the scientific exchange of clinical data to collectively collaborative for the advancement of science for new drug review. Coordinated with foreign authorities to allow investigations of potential sources of food borne illness. Assisted foreign governments clarify requirement of FDA’s policies for the importation of regulated products. Leveraged resources to enhance and reduce duplication of FDA foreign investigations in countries with have similar regulatory schemes for coordination of market access and approval. Maintained diplomatic relationships with foreign regulatory colleagues to support shared public health goals.Develop recommendations for harmonizing the sanitary and phytosanitary measures (SPS) and technical barriers to trade (TBT) and certification bodies, and laboratories.Key Achievements• Assisted in trade capacity building for Western Hemisphere countries and organizations. • Contributed in developing a strategic risk targeted import safety system for FDA regulated products. • Authorized Emergency Export of unapproved drugs and biologic clinical studies for export for investigation in foreign countries. • Coordinated epidemiological studies with foreign governments; orchestrated multi-international investigations and recalls.• Assisted in collaborating bilateral investigations of foreign firms for drugs and medical devices.• Contributed in developing Prior Notice regulations and guidance on Bio-terrorism regulations and prior notice. • Coordinated State Department communications with FDA organizational units.

Supervised 8 employees, including 2 Veterinarians and 6 compliance officers. Responsible for the enforcement and providing regulatory guidance involving pre and post-marketing veterinary products under of the Center’s program area. Responsibilities included reviewing compliance officers work to assure that the evidence gathered was supportable for regulatory action including recommendations seizure, consent decree, import detention were appropriately scientifically supported. Tasks included coordination with USDA/APHIS/FSIS, State Boards to clarify prescription use, BSE and certification of herds by Veterinary Services. Provided and handled consumer inquiries, consumer complaints regarding pet foods. Key Achievements• HHS Secretaries Distinguished Service Award for outstanding leadership in FDA’s counter bioterrorism preparedness. • Agency Committee member for Risk-Based Pharmaceutical Quality.• Developed Agency enforcement procedures and regulations for Bioterrorism Act of 2002.• Project management of Field compliance programs involving establishment inspections, medicated feeds under State contract, and BSE surveillance.• Developed the first consent decree enforcement action for failure to comply BSE (Mad Cow) regulations. • Processed 100% of enforcement cases involving the compliance of drug compounding, tissue residues, BSE, and labeling.

Performed laboratory QA Audits of FDA laboratories. Managed Field laboratory quality assurance program check sample program, and developed standard operating procedures for FDA Laboratory operations in Headquarter laboratories, Field Laboratories, and in District Offices for sample collecting and integrity.Served as contracts/grants coordinator for purchasing laboratory instrumentation and securing drugs for post marketing surveillance. Developed and crafted policy documents for privately laboratory submissions; “Guidance on the FDA Review of Analytical Data Generated by Private Laboratories”. Planned, orchestrated, managed, monitored FDA Field methodologies to provide the technological transfer of new, improved and validated methods suitable for regulatory analysis, including food safety and defective applications.Key Achievements• FDA Award of Merit for leadership and innovation in conjunction with the Presidential Initiation of the Safety of Imported Food. • Led laboratory/industry discussion groups for OOS policy guidance.• Credentialed Evaluator certified to conduct ISO/IEC 17058 laboratory accrediting body evaluation audits and 17025 assessments of testing laboratories in food testing scope.• Developing a risk-based testing strategy for post-market surveillance of pharmaceuticals.• Utilized methods to allow technology transfer of microanalytical techniques to detect bovine material in feed and food, from BSE affected countries.• Course advisor/trainer for sensory analysis of decomposed seafood to attenuate organoleptic analysis.• Developed sourcing with Department of Veteran Affairs for drug stockpiling and reuse of expired drug in the event of disasters.

1995–1999 - general hospital devices including, Latex gloves, condoms, sterilizers and infusion pumps, lamps etc. Reviewed establishment inspection reports (EIR) and process validationsDetermined compliance of good manufacturing practices (GMP) and Quality System Regulations. Prepared warning letters when required. Administered and gave guidance on regulations, and policies for medical device and radiological products.

1990–1995Food importation and Food safetyAdministered and gave guidance on regulations, policies and guidelines for foods, food additives, cosmetics and dietary supplements. Determined compliance and regulatory requirements for foods, cosmetics, dietary supplements and affirmed GRAS status for food additives. Determined the adequacy of GMPs, labeling, food additives, and sources of contamination for processed food. Gave guidance and explained import operations to businesses, brokers, private laboratories and governments.Evaluated and determined the compliance status of import detentions and inspection reports (EIR) for microbiological hazards, LACF, pesticide residues, filth and misbranding.Gave foreign workshops on FDA requirements which included labeling, LACF and AF requirements, pesticide residues and sanitary practices involving HACCP and GMPs.Coordinated activities with USDA Salmonella enteriditis Task force

1985–1990 - Reviewer CMC and BioavailabilityReviewed and determined new drug Chemistry Manufacturing Controls (CMC)’s for ANDA’s, DMF’s and Citizen Petitions.Gave guidance to present information for drug approval. 
Originated the guidelines for Active pharmaceutical ingredients (API)Developed CMC drug quality guidance for solid dosage forms and developed reviewing criteria for sustained- release drug products.

Analyzed regulated productsEvaluated bioavailability-testing laboratory practices in pharmaceutical establishments on team inspections.Developed court case evidence Written papers on new methods for food and drugs

Extensive experience and knowledge achieved through a distinguished 30-year FDA career. Accomplished a comprehensive multidisciplinary background in the Field and FDA Center Offices including ORA, CDER, CFSAN, CDRH, CVM, and the Office of the Commissioner. Career positions include operating in FDA’s critical mission functions as chemist, compliance officer, and international policy analyst. Accomplishments show proven experience and dedication to FDA’s mission by progressively reviewing new drugs, and effectively orchestrating FDA's headquarter enforcement strategies with drugs, biologics, foods, medical devices, and veterinary medicine. Originated and developed innovative approaches risk based pharmaceutical quality, laboratory testing standards, bioterrorism preparedness, and strategic importation enforcement policy. Facilitated Agency direction with technology transfer, global harmonization to allow collaboration of GxP with foreign regulatory authorities.