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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…
Optical Instrumentation Design, 3D Imaging, Confocal Microscopy, OCT, FTIR, Laser Scanning
Expert in the design and function of confocal microscope systems. Holder several patents for original confocal systems designed the semiconductor, glass, and other industries. Expert in 3D imaging technologies including laser triangulation, moiré', confocal imaging, and interferometry. Expert has designed…
Patent Law, Law, Medical Device Design, Drug & Perishable Material Stability, 510(k) Approvals
Expert's legal practice focuses on intellectual property and patents. He is registered to practice both in California for general legal issues, and nationally for patent issues through the USPTO. In addition to filing and prosecuting patents, he also has experience…
Usabililty Analysis, Human Factors, Premises & Product Safety & Liability
Ms. Expert has an extensive background in Human Factors, Ergonomics, Usability, and Research Psychology, totaling over 25 years of experience. Her career began in aviation and aerospace where she worked on the design of displays & controls for military and…
Electronics, Software, Sensors, Motion Control, Wireless, and Medical Devices
Expert and his senior team have many years of experience designing embedded circuits, instruments, medical devices, and software. Expert in all types of measurements. Analog circuit design, digital circuit design, and mixed signal design, as well as measurement and control…
Personalized Medicine, Genomics, Proteomics, Bioinformatics, Oncology, Biotechnology, IBD
As the director of the Employer Genomics and Proteomics Center and of the Dana Farber/ Harvard Cancer Center Proteomics Core, Expert has ample expertise in bioinformatics, since each of these facilities includes a whole core for bioinformatics. Expert supevises a…
Validation of Sterilization Processes and USP/AAMI Microbiology, Cleanroom Practices, Aseptics, etc.
Expert has years of experience in validating EO sterilization systems per ISO 11135, Gamma sterilization systems per ISO 11137, and Steam sterilization systems per ISO 11134/17665. This would also include troubleshooting and cycle development issues. He has worked with large…
Photonics, Fiber Optics, Laser Micromachining, SEM analysis, DWDM, Applied Optics
His area of expertise is design, modeling, characterization and development of photonic (fiber optic/optoelectronic/electro-optic) components and devices. His experience (50% industrial, 50% academic) includes 10 years in photonics, working with various technologies (glass fibers, InP, silica on silicon, ion exchange,…
Computer Forensics, Electronic Discovery, Internet Crimes and IP/Patent Analysis.
Expert has used BASIC on many computing platforms. He has designed, developed and implemented many batch programming languages. Representative computer science and engineering courses include: management information systems programming in Pascal, Cobol, Basic, Fortran, and C and C++ Programming. Engineering…
Mechanical Design: Automated Machinery, Rotating, Assembly, Gears, Machinability, Safety, Medical Eq
He designed many assembly machines in various industries, including biomedical, and semiconductor. Used all forms of electro-mechanical componentry. He has a patent for a unique mechanism. He has designed automated machines for 20 years, for all forms of industries, using…