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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…
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…
Molecular Oncology, Cervical Cancer, Breast Cancer, Immunohistochemistry, Diagnostics, and Pathology
Expert trained as a classical molecular biologist using viral model systems to examine regulation of gene expression and DNA replication in bacterial and animal viruses. His post-doctoral work focused upon regulation and malignant transformation caused by human papovaviruses and adenoviruses.…
Technical Commercial Development Support, Technology Transfer Food Non-Food Ingredients, Obesity
Expert K. Expert is the Principal of a consulting firm and has over 35 years experience in R & D., marketing, operations, process development and quality assurance. Expert engaged and managed a consulting business with network of experts that range…
Genomics
Expert worked with a team that cloned and expressed the enzyme T4 endonuclease VII for commercial distribution. He developed the basic assay of enzyme activity that was used in optimization and quality control of the enzyme. He is an author…
Food Science and Technology, With Emphasis on Meat and Dairy Products
Food safety has been a major consideration in Expert’s career, and as part of this, he has had particular interest in C. botulinum. He carried out fundamental research on the mode of action of the preservative sodium nitrite on this…
Cleanroom Technology
Expert has applied his background in the clean room industry to help those clients who are considering the use of clean rooms for their manufacturing process. He can assist with material alternatives and equipment selection that best fits into a…
Food Product Development
Expert has been an independent consultant in the dairy and food processing industries since 1992. His specialties include food product and process development and the identification and assessment of existing and emerging new ingredients, products, and process technologies. He has…
Biotechnology: All Areas of Business and Technology
Expert has extensive hands-on experience with, and knowledge of, deoxyribonucleic acid (DNA) probe technology, having worked in this area for 10 years. He used nucleic acid probe technology to characterize mammalian viruses and oncogenes while performing research supported by the…
Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness
Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. He has registered new chemical entities, novel dosage forms,…