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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…
Biotechnology Product Reviews, Biologics, Drugs & Medical Devices, FDA Litigation, Vaccines, etc.
Over 18 years experience with legal, scientific, business and regulatory issues affecting the research, development and commercialization of biomedical and information security products. Recognized expertise in strategy development, audit and due diligence, outsourcing, and FDA regulatory matters, including consulting for…
Clinical Applications, Microbiology, Biotechnology, Diagnostics, Immunology, and Custom Speaking
Expert has been involved in the identification of biological molecules associated with disease and infection with bacterial and viral agents. By applying molecular techniques to vaccine and infection models, he has identified immunological (antigenic) markers of bacterial infections of human…
Strategic Planning, Marketing, Sales, and Business Development
Expert has a proven track record in leading technology companies as president and in C-level executive positions. He holds an MBA and is certified by the Small Business Administration. His experience includes raising private financing, negotiating and setting up strategic…
Lean Manufacturing, Constraint Analysis/Resolution, New Product Planning, Manufacturing Engineering
Expert Kopstein (formerly Even) works with management and plant teams in the evaluation and implementation of advanced technology integration, efficiency improvement, waste reduction and productivity. Compliance and implementation of quality systems including aspects of ISO 9000, strategic planning, cost containment,…
Business, IT, and Knowledge Management
Expert's DBA(IS) studies provide a solid theoretical framework for understanding "the information economy," including knowledge management and e-business. In his regular work he has had practical experience of the tools that support knowledge management. For example: Expert has used e-mail,…
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…
Knowledge Management
Expert is an internationally recognized authority on knowledge-management theory and practice. A pioneer in the knowledge-management field, he began designing and guiding the implementation of knowledge-management solutions for Fortune 500 companies in the late 80's, well before such terms as…
Sterilization; Food & Drug Product, Packaging & Process Development; HACCP & Validation
Expert is a nationally recognized expert in aseptic, retort and autoclave, thermal processing and associated packaging of foods and drugs. He is well networked with the FDA food regulatory agency technical staff, academia, other process authorities, and research consortia. He…
Integrated Business/Technology Planning, Strategic Planning, Small/Medium Business Analysis
Expert has a deep understanding of virtually all aspects of business development, including customer needs; operations efficiency and effectiveness. He has provided advice and counsel for numerous small businesses and has managed in-depth studies of telecommunications and information handling requirements…