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Quality System & Regulatory Compliance, Life Sciences, Re-Engineering, 21 CFR Part 11
Business system design, business process re-engineering, and business re-engineering are at the core of the expertise she offers her clients. She has designed, written, and implemented business-focused quality systems for start-up companies and well as provided re-engineering support for out…
Healthcare IT Sales, Hospital Quality and Risk Management Software, and Healthcare Reform Software
Expert's specific experience with implantable devices comes from selling Orthopedic implants, in particular, total joints like hips and knees, and trauma devices in the Operating Room. Other products include Osteobiologics like pig skin for soft tissue repair. He facilitated over…
Baby Diapers, Non-Woven, Absorbent Products, Films, Wipes, and Consumer Tissue & Towel
Has extensive experience in the development and evaluation of absorbent materials of all types for the management of all types of human exudates. This includes cellulose absorbent cores, superabsorbent materials, foams, fibers and non-woven absorbent materials. Has commercialized over a…
Plastics and Medical Device Development, Plastics Processing, Material, Tooling, Failure Analysis
Expert is a huge proponent of concurrent engineering practices. He has helped numerous companies by helping them implement principles of concurrent engineering which requires all the departments from marketing to manufacturing and assembly to work together right from the inception…
Renewable Energy, Biofuels, Microelectronics, Semiconductor Packaging, Water Technologies, Agronomy
Expert has over 12 years of experience in Mergers & Acquisitions, representing both buyers and sellers. He has completed several deals and negotiated terms to maximize value. He has worked with clients to assimilate acquisitions regarding culture, economies of scale,…
Pediatrics and Pediatric Emergency Medicine
Over two decades experience in academic and clinical pediatrics. General pediatrics, Pediatric Emergency medicine, Outpatient and Primary Care Pediatrics; Pediatric Trauma; Expert has identified the following as a detailed list of expertise, specialties and interests in the medical field of…
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…
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…
Pharmaceutical Manufacturing, Research and Development, Education & Training
Expert’s primary experience in tablet manufacturing covered conventional pharmaceutical tablets for a variety of drugs and chewable tablets of antibiotics, utilizing both dry and wet granulation techniques and a variety of processing and tablet equipment. His experience encompasses all aspects…
Neurology and Pain Management: Board Certified in both
Expert has always had an interest in pain treatment. After concentrating primarily on treating headaches for several years, expert became further involved in evaluation and treatment of chronic pain patients and is also board certified in Pain Management. He has…