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Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms
As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into human clinical trials under IND controls. Four of…
Motivation, Teambuilding, Internet, Marketing, Public Relations, Training
Expert is a leading author, speaker, trainer and Internet technologist in the areas of quality management, service quality and the Internet's impact on business competitiveness. Based in Singapore, Expert has applied his hands-on background in business and operational management to…
Software Engineering, Testing, Integration, SQA, Real Time Systems, etc.
Expert is the principal author of DOD-STD-2167, Defense System Software Development, and served on the executive committees for many other software management standards (DOD-STD-2167A; DOD-STD-2168; MIL-STD-498; EIA/IEEE J-STD-016; IEEE/EIA 12207.0, 12207.1, 12207.2; ISO/IEC 15288, and others.) He has consulted with…
Strategy, Risk Management, Contingency Planning, Business Continuity
Expert (, pronounced "Gary") is a professional manager with over 28 years of extensive management experience including full P&L responsibility. He has a proven track record of increasing profits by reducing expenses and increasing sales/market share. He is experienced in…
Fastening to Aluminum, Plastic, and Other Soft Material, Taptite® Applications, Torque, Boss, etc.
Expert has extensive experience with a variety of threaded fasteners. He has worked with design engineers to develop the proper selection of fasteners, to determine assembly strategies, and to diagnose assembly problems for a whole range of products. He has…
Environmental Management, EMS Training, Spandex Production, etc.
Expert is a member of the US Technical Advisory Group to the ISO Technical Committee 207, which developed ISO 14001 and other international environmental management standards. He is an RAB-certified Lead EMS Auditor. He is experienced with establishing business environmental…
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…
JIT Manufacturing, ISO 9000
Expert (pronounced Lub-ben) teaches ISO 9000 certification classes independently and through the University of California at Berkeley and Pacific Bell. His classes range from an introduction to ISO 9000 documentation and program development to surviving an ISO audit. He managed…
Automotive Diagnostics
AUTOMOTIVE REPAIR. Expert has specialized experience in managing the development and distribution of PC-based serial tools and automotive diagnostic software. He produced a 10 year strategic plan to provide the next generation of service tools for future vehicle electrical systems.…
Product Safety and Liability
Expert is an established professional consultant providing board certified consulting services in proactive product safety, product design, and products liability management for industry, insurance companies, the legal profession, and government. He is a proven expert in product safety, defect analyses,…