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Navigation of the Maze of Environmental Regulations, Environmental Issue Analysis, Pragmatic Environmental Solutions, Environmental Regulations
Expert has the technical and scientific expertise to navigate the maze of environmental regulations. He concentrates on resolving the synergistic, interdisciplinary environmental issues posed by the discovery and remediation of toxic and hazardous chemicals. More importantly, he has the ability…
Air Quality Permitting
Ms. Expert is familiar with the air quality control regulations in several states. She has performed air quality regulatory compliance audits for numerous clients to ensure that their facility meets the current regulations. Ms. Expert has performed several air quality…
Environmental Management Systems
Direct involvement with environmental compliance and programs for multiple U. S. and International facilities. In depth working knowledge of Federal and many State and Local environmental regulations and ISO 14001 Standard. Responsibility for assisting facilities with implementation of Environmental Management…
Pharmaceutical Facilities, Pharmaceutical Manufacturing Processes, Facility FDA Compliance
In addition to having primary responsibility for numerous pharmaceutical construction projects over the last 15 years, Expert has also held several positions with pharmaceutical and medical device companies where he was responsible for the daily operations of facilities engineering, maintenance,…
Cleanrooms, Contamination Control, Ultrapure Media, Qualification and Validation, GMP, AMC
Expert has been active in aersol physics for more than 25 years. His PhD covers also the areas of environmental, indoor and cleanroom aerosols. He worked in a variety of scientific and technical projects covering the health effects of particles…
Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing
12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). These products are generating over $100 million dollars in…
Drilling and Completion Fluids, Chemicals, Processing and Drilling-Waste Management
CAREER PROFILE: - Expert has supervised the Drilling Fluids, Solids Control Equipment, Waste Generation & Waste Management in the international drilling sector since 1977. - As well as being a Drilling Fluids Specialist, he is very knowledgeable as regards drilling…
In-Process Analytical, cGMP Auditing, Polymer Characterization, Analytical Lab Design and Management
Expert has 32 years of industrial analytical chemistry experience. For the last 24 years of that period, he headed the analytical R&D organization of International Specialty Products, a $1.7B specialty chemical company (as of 2007). In his time heading that…
Equipment Design and Manufacturing Processes: Automated Machine, ATEX-CENELEC, and ISO Compliance
Expert managed and created the design and build of multiple machines and units used for paper converting, printing, plastics manufacture, packaging, food processing, aircraft components, vision inspection and material handling. He supervised electro/ mechanical design department, composed of engineers, designers,…
Substance Use Disorders, Healthcare, Call Center Operations, Compliance, Quality Improvement, Strategic Planning, Mail Order, and Healthcare
C-SUITE EXECUTIVE Expert is a results-oriented, tested “C” class executive with extensive experience at driving the strategic direction and enhancing the operational functioning of organizations. Reputation for serving as the executive point of contact for all stakeholders, recommending data-driven change…