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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…
Computer Architecture, Memory System Performance, System Validation, Engineering Managemen
Expert has over 15 years management and technical experience in semiconductor industry and academics with expertise in CPU and platform architecture, modeling and performance analysis, and validation. He has 9 patent applications filed; 4 issued and 25 refereed journal and…
Software & Technology: Product, Commercialization, M&A Strategy, Expert Witness
Expert stands out as a distinguished Senior Executive and Board Director, renowned for his transformative approach in product and commercial strategy. His dynamic leadership has been pivotal in accelerating growth, enhancing customer trust, and successfully turning around struggling ventures. Expert’s…
Supply Chain in Aerospace and Defense Sector
Expert is a supply chain expert who has managed over $2B spend in Aerospace and Healthcare sectors in domestic and international markets and contributed over $100M in cost savings to the corporations. He is expert in developing and using predictive…
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…
Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
Acoustics, Audio, Noise Control, MEMS, MIxed Signal Semiconductors and Sensors
Seismic industry experience including MEMS Sensor development. Semiconductor industry experience including automotive, sensors, infotainment and braking systems. MSE in ECE with major area of Electromagnetics and Acoustics. Member Acoustical Society of America and Institute of Noise Control Engineers. Electrical and…
Electronics Controller Engineering / Industrial Electricity / Manufacturing Safety
Senior Automotive Electronics Engineer with 33 years’ experience. Industrial Electrician for seven years prior. Managed embedded controller projects on very high volume vehicle programs, as well as engine (ignition) sensor applications. Having provided robust designs for manufacture in North America,…
Pharmaceutics
Expert is a process and chemical engineer with a Bachelor from Univercity Laval in Quebec City. He has more than 15 years experience in engineering, automation, validation of manufacturing equipments, clean utilities, pharmaceutical systems and computer systems (cGMP, GAMP5, CFR-21…
Environmental and Spatial Statistics, Especially Site Assessment and Remediation
Expert is a statistician with many years of experience in environmental statistics, especially related to site characterization and remediation. He has developed numerous environmental sampling designs for field projects and experimental designs for studies and has analyzed and reported the…