Medical Devise Regulatory Consultant with Class II and III Implantable Medical Device Experience: Cardiovascular Grafts, Surgical Mesh, Heart Valves, Periodontal Implants, Sutures and LigamentOver 25 years of experience in medical devices.Experienced in all aspects of medical device product development, including design, laboratory and clinical testing, manufacturing, labeling and quality systems.Extensive experience in medical devices pharmaceutical and in vitro diagnostics industries.Extensive experience with Class II and Class III implantable medical devices for cardiovascular grafts, surgical mesh, heart valves, periodontal implants,...

FDA Regulatory Affairs and Labeling Expert for Food, Cosmetics, OTC Drugs, Pet foods, and Medical DevicesFood and Drug Administration Regulations (FDA), in foods, dietary supplements, cosmetics, OTC drugs, pet foods and medical devices.Knowledge of allowable marketing claims for FDA regulated consumer products.Research and consumer health product development.Nutrition evaluation of food products.Product formulation and marketing.Undisclosed Company, Owner and Principal, 2001 - PresentProviding clients with over 20 years' experience in b...

Pharmaceutic Analytical Chemistry Consultant Expert in Drug Stability and Identification of API and Chemical Materials, (Pharmaceutical Chemist Expert on Forced API Degradation Studies and Drug Stability)Leadership of multi-scientist group responsible for the analytical characterization of drug substance and drug product formulations.Analytical method development and validation, drug substance and drug product characterization, stability evaluation, and analytical research and development project management.Broad background in the areas of physical-organic chemistry and analytical chemistry, chromatographic (HPLC, GC, SEC, Chiral) and spe...

Pharmaceutical Formulation Development and Process Development ScientistPharmaceutical formulation development and process transfer, serving over twenty five years' in the pharmaceutical industry.Develop products; solid dosages, liquids, capsules, research new technologies, and sustained release technologies.Experience with formulation, validation and scale up of all the above named disciplines.Supervisor and Manager responsible for staff consisting of formulators, packaging engineers, and equipment engineers.Clinical supply manufacturing and troubleshooting processes with successful transfer to process engineering and then to manufacturin...

Worldwide Pharmaceutical Expert Providing: Coordination and Technology of Pharmaceutical Products and Formulation and Development of Solids and ParenteralsSummaryExpertise in global product development, technology transfer/validation and business development.Designed and implemented development and registration strategies in U.S. and International arenas.Significant experience with all pharmaceutical dosage forms including peptides and novel delivery systems.Expert WitnessTwenty years of experience as an expert witness for pharmaceutical and formulation matters.

Experienced pharmaceutical laboratory manager and analytical chemist with expertise in GLP and GMP compliance and solid dosage forms.Extensive experience in pharmaceutical, nutraceutical and chemical industry analytical laboratories.Laboratory management and analytical laboratory improvement, cGMP and GLP compliance and problem resolution.Pharmaceutical process, cleaning and analytical methods validation.Solid dosage for OTC drug products.Responsibility for QA/QC functions for testing, complaint handling, customer audits and data analysis for over 300 different drug products.Training on cGMP and GLP compliance and problem resolution.Docume...

Ph.D. Food Science Consultant with Expertise in Food Products, Food Poisoning, and Food Regulatory IssuesFood Science and TechnologyFood SafetyFood PoisoningNatural Ingredient ClaimsFermentationAntimicrobialsProbioticsBotulismAnthraxSporesSpoilageListeria monocytogenesExpert Witness ExperienceConsultant and Expert Witness, various major food companies and law firmsNatural Ingredient Claims - furnished opinions in eight cases as defendant's expert for major food companies affirming that food ingredients such as citric acid, high fructose corn syrup, gelatin, xanthan gum, etc. are natural.Intellectual Property - provided opinion and testifie...

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...