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Aseptic Process Design, Airflow Visualization, HACCP, PAI Preparation, Cleaning Validation
Expert has performed validation of aseptic processes including technologies such as blow-fill-seal, high-speed automated liquid and powder filling lines, lyophilization, barrier and isolation technology, and bulk pharmaceutical and biological processes. Expert has developed an airflow visualization procedure to assist the…
Adhesive Consulting, Formulating, & Research in Structural, PSA, Hot Melt, Epoxy, Urethane, & Wood
Expert D. Expert has done adhesive failure analysis projects in connection with establishing cause in litigation cases or in research and production problems. For example, a wood millwork manufacturer claimed an adhesive was faulty, resulting in customer loss and damages.…
Contamination Control and Cleanrooms
The relationship between facility cleanliness and product cleanliness, between design criteria and operational conditions is one that even today oftentimes remains a mystery. Particle fallout is the source of visible contamination for contamination sensitive products during storage and assembly. While…
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…
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,…
Corporate Governance, Business Strategy Review, Business Intelligence/ Audit, and Compensation
Expert J. Expert has experience with board director and executive review, evaluation, and management of events as they change and occur in business. He believes that effective board and managerial control succeeds when strategies acknowledge a logical view of decision-making…
Failure Analysis and Objective Forensic Analysis: Ballistics
Expert has expertise in the the evaluation of metallurgical failures, including root cause analysis. He spent a sabbatical at Perkins Engineering in the UK conducting failure analysis in their materials lab and has 17 years experience conducting independent investigations in…
Biomaterials and Product Development R&D for Orthopedic, Cardiovascular, and Other Implants
Expert has helped assemble, and been lead author on 510(k) and IDE applications to the FDA. This has often included telephone conversations, and occasionally personal visits, with the FDA to discuss unique aspects of the devices and/or materials in the…
Technical Evaluation of Research and Development Efforts
Expert is a textbook author who is fully conversant with all aspects of high temperature superconductivity, from basic theory through fabrication techniques through device applications to economic analysis. He is currently serving as the principal technical adviser to a government…