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Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing
12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). These products are generating over $100 million dollars in…
Human Factors: Human Error and Accident Reduction, Performance and Safety into Complex Systems, etc.
Involved in accident analysis from the point of view of human error as a causal or contributory factor in the accident. Led the investigation for the Nuclear Regulatory Commission into the extent to which human error and training played a…
Drilling and Completion Fluids, Chemicals, Processing and Drilling-Waste Management
CAREER PROFILE: - Expert has supervised the Drilling Fluids, Solids Control Equipment, Waste Generation & Waste Management in the international drilling sector since 1977. - As well as being a Drilling Fluids Specialist, he is very knowledgeable as regards drilling…
Nondestructive Testing including Radiography, Ultrasonic, Liquid Penetrant, Magnetic Particle
Expert is an ASNT (American Society for Nondestructive Testing) Level III certificate holder in UT (ultrasonic testing), RT (radiographic testing), MT (magnetic particle testing), and PT (liquid penetrant testing). He has held these certifications for 23 years and has recertified…
Steel Applications using Engineered Alloys with Heat Treatment and Welding Knowledge
Most of his metallurgical practice and experience since 1985 has been with steel and other iron based metal products. His limited exposure to other metal products such as aluminum and titanium, etc, would be sufficient to provide basic information about…
Radiology Management: Operations, Generational Team Building
Expert has extensive knowledge in all radiology and imaging procedures and operations. He has directed and provided strategic oversight for hospital and outpatient ventures, and has direct working knowledge of all imaging modalities, including angiography, fluoroscopy, CT, computed and direct…
Electrical Engineering, specializing in Fire Investigation, Product Liability, Code Compliance and Associated Matters
Expert has performed forensic investigation of over 200 fires. He has also performed investigations associated with product liability cases. He has also testified in federal and state court on several occasions. Expert has performed consulting engineering concerning industrial personal injury…
QA/QC Issues in Civil Constructions in Oil Fields Especially in Deserts
He has knowledge and experience in dealing with major problems in construction of buildings like soil investigation, type of concrete to be used, soil classification for backfilling, proctor tests and compaction test inspections, types of concrete to be used. Dealt…
Missile, Nuclear, Oil/Gas Industry in Russia and Ukraine. World-Wide Space Launch Services/Markets
His area of expertise is competitive intelligence in Russian gas industry and Russian gas exports, including available and prospected gas deposits, pipeline network structure and capacity, gas transit issues, industry players in Russia, Ukraine, Turkmenistan, Uzbekistan, Kazakhstan, Belarus, Hungary, Poland,…
Data Analysis, Physics & Astronomy, and Technical Project Management
He has designed and built electronics for spaceflight and stratospheric balloon payloads. These electronics systems have included embedded computers running real-time and Linux operating systems, data acquisition electronics, particle detector electronics, and low-speed control systems. In each case, a small…