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FDA Compliance, Project Management, New Product Development, Validation, Cultural Transformation
Expert has audited many cGMP operations. A good audit starts with a good plan. Before starting an on-site audit, he reviews past audits. He notes indications of possible problem areas and items, if any, that were identified for corrective action…
Oil Terminal Operations Troubleshooting, Contract Negotiation, Mechanical Issues, Oil Inventory Loss
He is a hands-on manager in chemical and fuel oil terminals. He has rebuilt and maintained terminals, done inventory control, handled union negotiations, safety procedures, pollution control and prevention. He has been a peer manager, construction manager, and purchasing agent.…
Quality by Design, Good Laboratory Practices, Intellectual Property Security, ICH and FDA Compliance
As the former CIO of a Fortune 50 product development and commercialization subsidiary, and the executive tasked with building an ISO compliant records management program, Expert has had more than 15 years of experience planning, developing, implementing and then managing…
Wind Energy, Wind Turbine Design, Aircraft Icing and Anti-icing, Wind Turbine Icing, and Aerodynamics
In more than 30 years of activity, Expert has gained a wide and solid experience in fluid dynamics and applied aerodynamics, particularly in wind turbine and aircraft aerodynamics. In these domains, he has conducted research that covered analytical and numerical…
Software Application Development, IT Compliance, Pharmaceuticals, Large systems Release Engineering
Expert has designed a number of customer relationship management solutions (CRM) using different platforms such as salesforce.com, salespharma.net. Also, in his capacity as a director of technology for a number of companies he has been involved in the technical evaluation,…
Heat Transfer, Heat Pipes, Cooling Systems, Power Plant Equipment Design, New Product Development
Expert’s interests and experience extend over a wide range of air-cooled heat exchangers. Prompted mainly by the present day environmental concerns and scarce water resources, as well as by the more attractive maintenance-free operation of air-cooled units compared to water-cooled…
Facilitating Business Growth Through Commercialization of New Medical and Biotechnology Products
Expert has extensive experience supporting clients in pharmaceutical, medical and industrial markets. An electrical engineer by training, and the principal of his own consultancy for more than 12 years, he brings strong market, business development and technical skills to his…
Non-Profit Quality Improvement
Expert has developed and implemented quality improvement plans in large and small non-profit social service organizations. He has organized and facilitated quality assurance activities including peer record reviews, incident and accident reporting, grievance procedures, and more. He has consulted with…
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,…
Engineering Management
Expert has been involved with the re-engineering of new product development processes, creation of total quality management programs, and organizational structure changes for process engineering and research and development functions for two major medical device manufacturers (i.e. Johnson & Johnson…