API Quality Assurance, SOPs, batch production records and protocols, CAPA and SMF Activities, Clean Room ValidationsCompliance to cGMP Systems and Regulatory requirements. Application risk assessment, as applicable at various QMS documentation. Review of all the SOPs, batch production records and protocols (validation and qualifications) prior to the approval along with change request forms. Review of all equipment qualification documents like reactors, centrifuges, different types of dryers, blenders, powder process equipment etc., (DQ, IQ, OQ, PQ) and related test reports. Review of clean room HVAC qualification documents and relat...

Lab Testing Design: Drugs-Pharmaceutical Testing, Lab Operations, Maintenance, and Quality Control of Drug Testing Labs: Toxicology, Cannabis, Bioequivalence), Regulatory Requirements, BioequivalencSummary Over 17 years of drug testing experience on the development, validation, and application of analytical methods.  Equal experience in drug testing Labs design, operation, maintenance, and quality control of drug testing labs: Toxicology, cannabis, drugs, bioequivalence), cannabis regulatory requirements, bioequivalence studies, quality control studies, analytical laboratories’ quality assurance procedures.&n...

Consulting and manufacturing expert focusing on silicone products and technology. Manufacture customized formulations of specialty silicone adhesives, sealants, gels and coatings.Custom manufacturing and formulation of specialty silicone adhesives, sealants, gels and coatings.Owner of fully equipped labs to develop and characterize coatings, both thixotropic and self-leveling sealants and adhesives, thermally conductive products, high temperature stable products, greases, compounds, and many cure chemistries.Specific silicone experience including: Silicone coatings and adhesives (both thixotropic and self-leveling), silicone sealants, the...

Power Train Expert Specializing in Research and Development, Advanced Engineering, Technology Planning and Strategy.Senior Power Train Technologist specializing in research and development, advanced engineering, technology planning and strategy.Pragmatic, results-oriented engineering executive and mentor with extensive background in leading powertrain developments and technical strategies for global companies.Proven ability to lead developments of "game changing" technologies.Emissions and after treatment.Renewable fuels and CO2 reduction.Technology assessment and planning.International training and team building.Core competency and new bu...

Dietary Supplement and Functional Food Consultant Specializing in NPD Innovation and Quality/GMP ComplianceNatural product development and formulation; vet new product opportunities: Navigating IP infringement avoidance, scientific validation, efficacy, dosage, market viability, and regulatory compliance. Natural product ingredient assessments, technical review, and scientific approval. Provide marketing content, direction and guidance for new product launch. New product positioning and marketing strategy, product naming and tag line creation. Natural product: Product quality and marketing integrity: IP protection, regulatory complia...

Electrical Power Systems Consultant: Electrical Contacts, Electric Power Lines, Industrial Faults (damaged facilities, loss of product) Electrical Equipment Condition, Solar Use Permits, Fiber Optic FeasibilityRural power systems for municipally owned power systems, investor owned utilities, industrial power systems, electrical testing contractors, and other professional firms.Engineering and operations management reviews and operational plans for rural electric cooperatives.Power systems planning-systems analysis (distribution and transmission) design, least cost planning, economic analysis, and alternative plans.Reliability critical com...

Invention Disclosures Review in a Wide Range of Technologies in the Material and Chemical Sectors• Materials and surface scientist, process engineer, technical lead and technology consultant. • 14+ years of experience in resins, nanomaterials, adhesives, composites and coatings. • 6+ years of industrial experience in applications development for new markets, process development and scale-up to pilot, new product improvements, analytical testing, etc. • 2+ years of law firm experience in patent application drafting, prior art analysis, and technology review. • 20+ peer-reviewed publications and 800+ citations. • Expertise...

Consultant for Internal Combustion Engines, Combustion Technology, Alternative Fuels, Emissions and Exhaust TreatmentConventional and alternative fuels for passenger cars and trucks.Gasoline and diesel engine combustion.Exhaust gas analysis.Gasoline and diesel exhaust after treatment (TWC, DOC, fuel reformer, LNT, SCR, DPF).Undisclosed University, Assistant Research Scientist, 2003 - PresentGasoline combustion technology.Exhaust after treatment and catalysis of gasoline engine emissions.Exhaust hydrocarbon identification and...

Instrument and Electrical (I/E) systems expert in the chemical, petrochemical and power industries.Over 38 years Instrument and Electrical (I/E) systems in the chemical, petrochemical and power industries.Project management for chemical plant I/E improvement projects, providing 30 years' experience.Supervising technical personnel for over 40 years.Broad understanding of civil, mechanical, piping, and structural engineering principles.Field Transmitter Engineering Standard and the Control Valve Engineering Standard Sponsor.Undisclosed Company,...

Petrochemical process engineer expert in process evaluation, modeling heat and material balance, designing, and start-up of ethylene plantsProcess evaluation, development, design, and start-up of petrochemical plants.Fluid, heat and mass transfer theory and equipment as currently practiced.Heat and material balances, process engineering.Ethylene plant design, troubleshooting and operation.HYSYS, SIMSCI PRO II, STELLA process modeling programs.Modeling chemical processing equipment.Industrial short course training, including international clients.Collagen and other protein processing.Polyvinyl alcohol and polyvinyl acetate plant engineering...