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Material Science and Metallurgy
FAILURE ANALYSIS Expert's failure investigations have encompassed a wide range of oilfield products including, but not limited to, wellhead and Christmas tree equipment, rock bits, OCTG, motors, packers, and downhole tools. Failure investigations have included but not been limited to…
Pharmaceutical Science; Preformulating, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation
As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…
Digital Transformation: Risk and Engineering
Working with global and international clients and organizations to address emerging, evolving and rapidly changing enterprise risk, governance, risk and compliance, operational risk and resilience, business continuity, crisis management, organizational and digital transformation, as well as control system testing, review,…
Microbiological Contamination Control
A principal with his eponymous consulting firm, Expert has amassed 30 years of experience in academia, industry, and consulting. The majority of his research and consulting work has been in the area of microbiological contamination detection and mitigation for pharmaceutical/biotechnology,…
IVD Assays and Diagnostic Tests Development
Expert's areas of expertise include the following: IVD (in vitro diagnostics) clinical laboratory regulation molecular diagnostics blood assay diagnostic instrumentation assay development CLIA-88 (Clinical Laboratory Improvement Amendments of 1988) clinical laboratory regulation quantitative risk analysis (risk assessment) laboratory management GLP…
Analytical Chemistry: HPLC, LC-MS, Bioanalysis. R&D projectmanagement; writing of publications
Expert’s scientific expertise includes the development, optimization and validation of quantitative bioanalytical methods for small molecules, peptides and biopharmaceutical drugs as well as for their metabolites in biological fluids (plasma, urine, tissue, etc.). These methods are essential for the pharma…
Computer Aided Design, Finite Element Method, Mechanical Engineering, Biomechanics
Expert is the Director of the Medical Engineering Research Group at Employer and a Senior Lecturer in Mechanical Engineering. Since completing her PhD in 2001, she has been applying mechanical engineering solutions to medical problems, mainly in orthopaedics. Expert's research…
Analytical Optical Spectroscopy, Chemometrics, Petroleum, Polymorphs and Diagnostics
Expert has taught courses and performed investigations in many areas of analytical chemistry including analytical spectroscopy, qualitative analysis, quantitative analysis, computer programming methods, algorithm developments and instrument developments. The primary goal of his research is to develop practical analytical instrumentation…
Nuclear Power/Accidents, Radiation Detection, Radioactive Waste, Environmental Science, Forensics
Expert, a licensed professional engineer (P.E.), has earned B.S., M.S., and Ph.D. degrees in nuclear engineering. Expert is a former Visiting Full Professor of Nuclear Science and Engineering at the Massachusetts Institute of Technology. In addition, he is a former…
Psychopharmacology, Drug Development, Medical Devices
Expert's training in psychiatry has focused on biological psychiatry (the biological basis of psychopathology) and on psychopharmacology. He currently directs the Developmental Biopsychiatry Research Program and the Laboratory of Developmental Psychopharmacology at McLean Hospital/Harvard Medical School. He has a broad…