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Pharmaceutical Quality Assurance
He possess thorough knowledge of GMP / GLP regulations like US FDA, WHO GMP, ICH, MHRA, ANVISA, requirements of cGMP documents (SOP’s/ Change controls/ Deviations) as per various regulatory agencies. He had actively participated in various international regulatory inspections (USFDA…
Process Automation: Process Control, Computer System Validation, Alarm Management, & Modeling
Expert served for several years as a major pharmaceutical company's chief Quality Assurance GMP/GLP computer validation auditor. He chaired the team that developed the company's first policy and guidelines regarding computer validation,- and served for several years as the company's…
Explosives Instrument Detection, Trace Explosives Chemical Analysis, Optical Spectroscopy, Polymers
Expert has spent over 15 years working in the field of analytical chemistry of various labile organic compounds and macromolecules. He worked on the quantitative and qualitative analysis of highly involatile species that required special sample preparation and processing. These…
Adhesives for Medical Device, Biotech, Pharmaceuticals, Aerospace, Materials Science, QA, QC
With a PhD in organic chemistry expert has spent over 25 years developing adhesives, resins and advanced composites for a variety of applications. He started at the bench chemist level and worked his way up into R&D management. Some of…
Environmental Chemistry: Analytical, Fate and Transport, Statistics, Validation, Data Management
Fundamental to almost every decision made in the environmental sciences are chemical analytical data describing the nature and extent of contamination or monitoring and environmental process or condition. It is rare, however, to find individuals who understand chemical analytical data…
Drinking Water Quality
In his work with water quality, he was responsible for the interpretation of and compliance with the Surface Water Treatment Rule, the Coliform Rule, the Disinfection/Disinfection By Products Rule, the Lead and Copper Rule, and the Radionuclides Rule. By virtue…
Laboratory Management; Quality Assurance/Control
Expert has demonstrated expertise with the design, development, and start-up of laboratory facilities. These facilities have been used for analytical testing, physical characterization, environmental sample conditioning, and drug stability testing. He has specified and implemented purified water systems, sample conditioning…
Trace Metals Analysis, Fluorescence of plants, chemometric data analysis
Expert has worked with analytical atomic spectroscopy for more than 25 years. His knowledge of the application of this technique to the determination of trace to ultratrace concentrations of metals in aqueous samples is grounded on a continued search for…
Supercritical Fluid Technology
Expert M. Expert has extensive experience in the theory and practical use of capillary GC. He has considerable knowledge in multidimensional strategies, troubleshooting, capillary column technology, injector designs, detection schemes, and current applications. He has also conducted many training courses…
Experiment Design and Optimization, Response Surface Methodology, Factorial Experimentation
For over three decades, Expert has been consulting and training technical people in the areas of experiment design. Expert has played a key role in developing commercial computer software for the design and analysis of experiments. He currently teaches several…