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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…
Food Technology, Nutraceuticals, Natural Health Products, Quality Systems
Expert has extensive knowledge and experience in the food science area, with specific focus on food ingredients. With over 20 years experience in food product development, with emphasis on ingredient processing, he has specific expertise in the development of powder…
Toxicology, Cyanide, Toxic Metals, Environmental Health, Risk Assessment
Expert MD is a physician specializing in the evaluation and treatment of patients who have developed injuries or illness as a result of chemical, physical or biological agents. She is Board Certified in: Toxicology – through the American Board of…
Agronomy, Livestock Waste Management, Crop Consulting
Expert has expertise in waste management practices recommendations based on federal and state laws, best management practices, and agronomic principles for ag feedlots. Scouting and recommendations for production of crops such as: variety selections, soil sampling, soil test interpretations, nutrient…
Agronomy, Regulated (GMO) & Regulated Crop/Seed Production, Management, USA, International shipments
Expert's experience in agricultural development includes introduction of center pivot irrigation for irrigated corn to western Nebraska in the early 1970's when the area had previously been considered only as a dry land wheat production land. He also worked in…
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…
Pharmaceutical Quality Assurance
He possess thorough knowledge of GMP / GLP regulations like US FDA, WHO GMP, ICH, MHRA, ANVISA, requirements of cGMP documents (SOP’s/ Change controls/ Deviations) as per various regulatory agencies. He had actively participated in various international regulatory inspections (USFDA…
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.…
Natural Gas Distribution, Explosion Investigation & Cause, Federal & State Regulations
Expert has held multiple positions at the forefront of natural gas industry issues, where he has over twenty years of field experience working as an emergency responder and gas leak investigator for a natural gas utility company. Expert develops and…