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Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…
Construction Safety
Expert has over 40 years' experience in worldwide professional safety. His work experience includes tenure as Corporate Safety and Security Director for four Engineering, Design and Construction Management Firms. This work has involved over 600 worldwide construction projects. Additionally, as…
Flexible Packaging Materials; Film Extrusion, Extrusion Lamination, Food Packaging, and Food Packaging Safety
Fellow, Society of Plastics Engineers Inductee, Packaging Hall of Fame Expert has spent over 35 years in the development and application of functional materials for a variety of packaging and non-packaging applications (process and platforms). He has developed various multi-layered…
Heterogeneous Catalytic Hydrogenation for the Production of Fine Chemicals
Expert has applied his organic chemistry/heterogeneous catalysis/reaction engineering background to the development of processes for the production of pharmaceuticals, vitamins and nutraceuticals, agrochemicals, flavors and fragrances, liquid crystals and fine chemicals as well as base chemicals. He has broad experience…
CRO in Medicinal Chemistry, Pharmaceutical Chemistry, API, CRAMS, Speciality Chemicals, Training
Expert received his PhD in synthetic organic chemistry from the University of Hyderabad. He has 2 years of post-doctoral experience in synthetic and physical organic chemistry from University of Houston. He also worked on chiral polymers and energetic materials during…
Process Design
Expert is founder and president of a Houston based process engineering and project management firm focusing on petroleum refining, chemical, and gas processing industries. Expert has 25 years of experience involving process design, process troubleshooting equipment specification, equipment design, process…
Process & Control Engineering, Operational Excellence, Reliability & Expert Witness
Multi-talented and versatile leadership & management skills with geographically and culturally diverse teams & projects. Broad and diverse experience in the refining, petrochemical, chemical, and biofuels industries. Project management skills include project definition, budget, scope & proposal development, and cost…
Chemical Plant Safety Services, Hazard Studies, SIL, Risk Assessment, DSEAR, Water Hammer
Expert's main area of interest is chemical plant and process safety. He has led HazOp [Hazard and Operability] studies on many plants from large scale, high hazard plants using well-established technology (e.g. manufacture of hydrogen fluoride, high density polyethylene, etc)…
Process Safety, Risk Assessment/Management Major Accident Risks, Hazards and Land Use Planning
Process Safety has been the main focus of Expert's work as he seeks to assist companies avoid accidents completely (by eliminating hazardous materials or processes) or prevent them through providing protection (containment or control). In some circumstances the only available…
Thermosetting Polymers, Product Development Process, New Business Development
Expert is a nationally recognized authority in thermosetting polymers. He has developed a fundamental understanding of thermosetting polymers including detailed experience in the rheology of curing systems (chemorheology), cure kinetics, physical property measurements, dielectric measurements of curing, and process development.…