Good Manufacturing Practice Expert Witnesses

Regulatory Affairs, Food Companies, Dietary Supplement, GMP, Good Manufacturing Practice, Food Processing, Preventive Controls, Allergen, Manufacturing, Packaging, Inventory Control, Supply Chain, 21 CFR 111, 21 CFR 117, Food Safety Plan, Hazard Analysis, Contaminant, Quality Management, Contract Manufacturing, Label, Product Development, Document, FDA

FDA & global regulatory affairs, quality assurance, & cGMP compliance, Chemistry and Manufacturing Controls (CMC), Active Pharmaceutical Ingredients (API), New Drug Application (NDA), Abbreviated NDA (ANDA), Drug Master File (DMF), Biologic Licensing Application (BLA), Warning Letter, Form 483, New Chemical Entity (NCE), Labeling, Current Good Manufacturing Practice (cGMP), United States Pharmacopeia (USP), Quality assurance, Quality Control, Standard Operating Procedure (SOP), Regulatory compliance, Due diligence, Technical transfer, Analytical methods validation, Complete Response Letter (CRL), Consent Decree, 21 CFR 210 & 211, 21 CFR 111, Quality System Regulation (21 CFR 820), 510(k), PMA, Combination products, Drug-device products, Cosmetics, Nutraceuticals, solid oral dosage, Creams & Ointments, Oral solutions, Sterile injection, black-box warning, Sustained release, Controlled release, Capsule, Formulation, Pharmaceutical development, Corrective & Preventative Action (CAPA), Marketing Authorization Application (MAA), Type I & II variations, Deviations, Investigations, Good Distribution Practice (GDP), Supply chain management, Radio-labeled, Clinical Trials Application (CTA), Investigational New Drug (IND).

GMP Compliance, Regulatory Affairs, 21 CFR Part 111 and 21 CFR Part 117 regulations, Quality Assurance, Environmental Health, & Safety (EHS), OSHA Compliance Food Safety, Hazard Analysis Risk-Based Preventive Controls, Facility Audits Process Validation SOP, Development Third-Party Audits Supplier Quality Management Certification, Management (GMP, Halal, Kosher, Organic)Customer Complaints, Investigation Corrective, & Preventive Actions, (CAPA) Product Safety Root Cause Analysis Training & Compliance, Programs Facility & Equipment, Qualification Water Treatment Systems, Manufacturing Process Optimization, Erection & Commissioning Process, Engineering Regulatory Inspections, Emergency Action Planning, Hazard Communication (HAZCOM) Safety & Risk Management, Supply Chain Compliance Technical Documentation, Dietary supplements.

Biomedical Engineer, Electrical Engineer, Certified Clinical Engineer, Patent, Medical Devices, Product Liability, International Health Care Safety Professionals, Biomedical Devices, FDA Neurological Devices, Laser Device Instructions For Use, Manuals, Labels Warnings, Department of Health Human Services, FDA, Kugel Mesh Hernia Patch, Radiological Equipment, FDA Regulatory Issues, Medical Devices Life Cycle, Medical Device, Equipment, Safety, Biomedical, Clinical engineering, infusion pump, ESU, laser, Monitor, Equipment Labeling, Healthcare technology, compliance, Risk, Equipment repair, Maintenance, Medical technology life cycle, Wireless networks, FDA, Telemedicine, Regulation, Defect, patent IP.

Sediment Contamination, Semi-Volatile Organic Compounds, Site Historical Contamination Assessment, Site Reconnaissance, Soil Conductivity Survey, Soil Contamination, Soil Testing, Solvents, Total Petroleum Hydrocarbons, Toxic Metals, Volatile Organic Compounds, Wood Preserving, Wood Treating, Environmental Engineering, Environmental Science, Air Pollution, Ambient, Air Quality Testing, Noise, Soil, Sediment, Groundwater, Surface Water, Water Treatment, Purification, Contaminated Dust, Ecosystems, Abandoned Legacy Sites, Hazardous Waste Management Facilities, Refineries, Chemical Plants, Fossil, Nuclear Power Plants, Geothermal Energy Plants, Manufacturing, Commercial Facilities, Pipelines, Power Transmission Lines, Oil, Gas Exploration

Software, Databases, Source Code Comparison, Abstraction, Filtration, Comparison, Communications, Internet, Web, Ecommerce, Client Server, N Tier Technology, Graphics, GUIs, Sensor Processing, EEG Analysis, GPS Tracking, Pattern Recognition, Computer Linguistics, Content Analysis, Patent Analysis, Patent Licensing, Algorithm Development, Medical Records Database Analysis, Software Architecture, Simulation, Reliability Engineering, Probabilistic Analysis, Statistical Analysis, Bayesian Analysis, Markov Analysis, Monte Carlo Simulation, Hidden Markov Models, Embedded Systems, Point Of Sale Systems, Geographic Information Systems, Distributed Computing, Systems Development, Industry Practices, Networking Protocols, Medical Devices, Patent Prosecution, Patent Litigation, Business Methods, Text Processing, Radar, Sonar, Financial Software, Control Systems, Ultrawideband, Fourier Analysis, Work Flow Tracking, Work Flow Analysis, Knowledge Based Systems, Project Planning, Technical Marketing Support, Manufacturing Execution Systems,

Psychology, Mediator, Pre-Hire Assessment, Coaching, Hiring, Testing, Staff Development, Ligitgation Support, Executive Teambuilding,

Engineer Medical Device, Engineer Biomedical Surgical, Ear Nose Throat, Artificial Organs, Implants, Therapeutic Devices, Extracorporeal Devices, Neurostimulation Devices, Non invasive Monitoring, Device Evaluation, Testing, Stem Cell Based Technologies, Biomedical Engineering Technology, Solutions, Medical Clinical, Medical Membrane Technology, Imaging Ultrasound Devices, Blood Manipulation Technology, Device Biocompatibility, Blood Devices, Medical Clinical Info Systems,