Senior consultant in pharmaceutical and medical devices with emphasis in blood testingPharmaceutical and biotechnology quality assurance and control (QA, QC.)Regulatory compliance, consent decree and FDA batch record reviews-investigations; European audits.Plasma and blood collection centers and computerized donor record files.Blood and plasma quality assurance and control.Pharmaceutical QC methods development and review.Pharmaceutical validation of laboratory methods.Quality systems, quality control laboratory and development of standard operating procedures.Regulatory compliance audits; quality system audits.Vaccine stability, raw materi...

Pharmaceutical Quality Systems Implementation, Training and Audit ConsultantForty years of pharmaceutical and biotech industry experience - Production and development environments.Validation (computerized systems, equipment, processes), pre-acquisition - due diligence, quality assurance, compliance, quality control, research and development, technology transfer and clinical operations.Small and large molecule and vaccines, (Flu, Anthrax, and Rabies).International and domestic experience and assignments, (Europe, China and India).Exit strategy development, tracking and adjustment.Working with small, medium and large firms, assisting and man...

Expert manufacturer of high protein low carbohydrate foods and beverages including soy isolate, high energy bars and beverages, fish protein, whey protein, infused fruits and vegetablesManufacture of high protein low carbohydrate bar formulations.Production of high energy and sport beverages; fruit and vegetable juice processing.Facility startup for sugar replacement blends; infused fruits and vegetables, soy isolate, fish protein concentrates, whey protein concentrates.Food product formulation, herbal extraction, food dehydration.Quality Assurance and SOP's for food and dairy products.Food industry membrane processing.

Expert for manufacture of glycolic acid and esters and handling of hazardous chemicals such as phosgene, anhydrous ammonia, methylamines, sulfur trioxide and dimethylsulfate.Registered Professional Engineer in West Virginia, Ohio and Pennsylvania.High pressure chemical processes (over 500 atmospheres) for both glycolic acid gaseous and liquid applications.Use of exotic materials of construction in difficult process conditions, e.g. titanium and silver.Glycolic acid production and the esterification of glycolic acid.Decolorization and ion exchange for chemical processing.Handling of highly hazardous chemicals, e.g. phosgene, anhydrous ammon...

Organic chemist expert on polycarbonate resin manufacture, quality, formulation, blending, compounding, grades and applications.Polycarbonate product developments for specific application needs.Troubleshooting on polycarbonate production problems.Knowledge of the plastics additive suppliers and polycarbonate raw material suppliers.Polycarbonate manufacturing from pilot scale to plant scale.Recovery of catalysts for better economics and to comply with EPA regulations.Developed polycarbonate blends, PC/ABS, PC/polyester, to suit market needs.Led global team to harmonize the additives for the polycarbonate product line.Polypropylene products,...

Technical operations consultant on sterile packaging, electronic materials, injection molding, elastomeric resin compounding and compositesSterile packaging, design, production and testing of medical devices.Microbial film barrier of porous materials.Electronic printed circuit board production and assembly.Electronic PCB failure analysis and process troubleshooting.Organic matrix composite material production and troubleshooting.Injection molding of thermoset and thermoplastic resins.Compounding of high performance elastomeric resins.Material selection/optimization for harsh environments.

Consultant skilled in project management, operations management, and quality management with emphasis on medical device manufacturing, sterile products, and designs for manufacturing. Special expertise in medical devices of cutting blades and surgical tools.Manufacturing process startup, integration, improvement and relocation.Project management, operations management and quality management with emphasis on medical device manufacturing.Engineering and product design for manufacturing.Manufacturing of sterile products on a global basis.Production process startup, integration, improvement and geographical relocation.Project management, oper...

Over 15 years experience in pharmaceutical manufacturing of solid dose, liquid/semi - solids, and transdermal products.Expert in solid oral, liquids and transdermal pharmaceutical dosage forms.15 years of pharmaceutical Quality Assurance, research and development and commercial manufacturing experience.Process expertise in development and manufacture of solids, liquid and transdermal dosage forms.Supply chain experience in warehouse and distribution operations, including design and operation of Automated Storage and Retrieval Systems (AS/RS).Technical expertise in qualification of equipment, utilities and facilities, cleaning and process v...

Consultant for Medical device FDA/ ISO Regulatory Compliance.Medical device FDA/ ISO regulatory compliance.Design control systems, both hardware and software, for medical devicesRisk analysis, vendor qualifications and documentation related to medical devices.Software and process validations.Design and manufacturing engineering in flowmeters.Contract Manufacturer Organization (CMO) selection and qualification for medical devices.Drawing and document control systems, configuration and management.Human factors programs.Component acceptance procedures/ non conforming product disposition.Audits, gap analysis and response to FDA 483 forms and w...

ISO 9001 system implementation, statistical methods and auditingDeveloping systems to meet the requirements of ISO 9001.Implementing and maintaining ISO 9001 quality management systems.Internal auditing of ISO 9001 quality management systems.Writing effective procedures to meet the requirements of ISO 9001.Use of statistical methods and Taguchi design of experiments.Pack cementation processes for aluminizing, chromizing, boronizing and siliconizing.High temperature oxidization resistant coatings, including MCrAlY (molybdenum, chrome, aluminum, yttrium) and aluminide.Plasma spray coatings applied for wear or oxidation resistance.Ceramic co...