Consultant for Medical Device Software and Compliance and ValidationFDA and ISO compliance, particularly for medical devices and related software systems.Quality system auditing.Supplier quality assurance, audits and FDA checks compliance.Software verification and validation.Software project management.Process assessments and improvement.Computerized systems validation.Software risk management.Software life cycle documentation.Quality system training.Independent ConsultantAbbott Laboratories Diagnostic Division, Irving, TX, 1986 - 2009Manager, Division Software Quality Ass...

Past FDA Employee Expert in Food, Drug, and Medical Devices Safety and Regulatory ComplianceFDA inspection and investigation of medical devices, pharmaceutical, biologics and food facilities to enforce the FD&C Act.Conducted international FDA medical device and pharmaceutical inspections in 18 countries.Medical device Quality System and pharmaceutical cGMP regulations and principles.QS regulation inspections of the following types of medical device process technologies: Electronic/electrical, sterile (ETO, dry heat, steam, irradiation), plastic, in-vitro diagnostic, metal CNC machining and a variety of product types.Pharmaceutical cGMP re...

Specialists and expert witness in silicone medical devices and related chemical, physical, and biocompatibility testing to support 510k, IDE, and PMA submissions.Specialists in the characterization and qualification of silicone medical devices.Chemical, physical, and biocompatibility testing to support 510k, IDE, and PMA submissions to FDA, particularly related to silicone medical devices and silicone applied technology.Pre-clinical chemical testing and evaluation.Testing protocol preparation; testing protocols of silicone based medical devices.Mechanical testing for manufacture of implantable silicone devices.Polymer characterization, spe...

Consultant bioengineer expert in biomaterial science, nanotechnology, biosynthesis of polymeric biomaterials for implants and drug delivery.Synthesis of biomaterials and biomineralization, wherein a living organism provides an environment that controls the nucleation and growth of unique mineral phases.Synthesis and characterization of self-assembly of block copolymers.Nanostructured composites and polymeric biomaterials production and analysis.Consulting on artificial implants, drug delivery systems and medical devices

Chemical and Biopharma Trade Consultant, Licensed Customs BrokerOrganic and medicinal chemist with import, export, and economic sanctions experience. Provides import (Harmonized Tariff Schedule) and export (Schedule B and ECCN) classifications. Assists with import requirements of partner government agencies e.g. USDA, FDA, FWS. Chemical and biopharmaceutical product import classifications for the global Harmonized Schedule (HS) and the Harmonized Tariff Schedule of the United States (HTSUS). Export control regulatory compliance of the U.S. Department of Commerce, Bureau of Industry and Security (BIS). Export classifications to give Sc...

Expert in analytical chemistry for pharmaceuticals, FDA issues and detection of bio hazards for Homeland SecurityCenter for Drug Evaluation and Research (CDER), former FDA employee.FDA review of new drug (NDA) and generic drug (ANSA) application submissions, FDA national Field operations, FDA compliance.Research and development programs related to homeland security.Department of Defense force protection and agent detection (novel devices, sensors and samplers) for the detection and identification of chemical and biological agents.Technology related to infectious disease countermeasures.Analytical chemistry related to drugs.Pharmaceutical a...