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Transportation: USDOT-USEPA-NHTSA-CARB, Safety Policy, Environment & Energy Programs, Gov’t Relation
Expert is totally knowledgeable in all the fields of automotive systems safety( passive and active ). He has advised Volvo( the leader) of trends in the market place as well as the governmental trends in the US and Canada. He…
Customs, Imports; Trade Policy & Compliance; Global Trade Strategy; Finance; International Business
Expert has created and implemented many international trade compliance, training and self-assessment programs. Her experience covers a broad range of industries (medical and health care, food and agriculture, consumer electronics, automotive, etc.) for various Fortune 500 companies, among others. She…
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…
Operational Streamlining, Organizational Transformation, Program Management, and Technology Integration
Expert has extensive experience in Software Project Management of over 20 years in federal and commercial sectors. He has managed projects involving application development, system integration that required integration of commercial software products (COTS) with application code, software conversion, and…
Medical/Surgical Device Design, Management, Marketing, Regulatory
Expert is a results-oriented professional with proven domestic and international experience in health care administration, medical devices, marketing, staff development, product development and management, luminary and customer liaison, public relations, technology assessment and transfer, intellectual property, research and development, clinical…
Agriculture, Horticulture, Loss Management
A successful twenty eight year career in agricultural chemicals involving retail management, field sales and product development roles. Industry experience with commercial, technical, research and practical hands on experience in a wide range of horticultural and agricultural crops has provided…
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…
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…
Protection Design, Testing, Data Analyses, EMP, EMC, COMSEC, ZONING, TEMPEST
The electromagnetic protection process is an evaluation of risk assessment against criteria (EMP, EMI/EMC, TEMPEST, EM-health). The entire process covers mainly: risk evaluation, design, construction, maintenance and testing. Starting from the risk evaluation, the different aspects of electromagnetic protection can…
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,…