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Quality System & Regulatory Compliance, Life Sciences, Re-Engineering, 21 CFR Part 11
Business system design, business process re-engineering, and business re-engineering are at the core of the expertise she offers her clients. She has designed, written, and implemented business-focused quality systems for start-up companies and well as provided re-engineering support for out…
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…
Airplane and Helicopter Research, Design and Analysis
During the latter part of his tenure at NASA Langley, Expert served as the Assistant Branch Head of the Subsonic Aerodynamics Branch, and was the only Army researcher ever to serve in a NASA management position. He was principally responsible…
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…
Chemical Hazard Consulting, Environmental Compliance, Occupational Safety
He has applied his knowledge of employee chemical hazard communication to creating chemical labeling compliant with all world-wide regulations. Expert has extensive knowledge of chemical regulations pertaining to hazard communication in the US, Canada, EU, Japan, and other national requirements.…
Oil & Gas, Environmental Law, Regulation, Petroleum Geology & Mineral Leasing
As a practicing environmental attorney for 10 years (1995-2005), he represented several clients in matters involving air quality compliance and alleged environmental effects due to air pollution. He reviewed several air pollutant effect studies and dispersion models, and conducted preliminary…
Pharmaceutical Manufacturing, Research and Development, Education & Training
Expert’s primary experience in tablet manufacturing covered conventional pharmaceutical tablets for a variety of drugs and chewable tablets of antibiotics, utilizing both dry and wet granulation techniques and a variety of processing and tablet equipment. His experience encompasses all aspects…
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…