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Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms
As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into human clinical trials under IND controls. Four of…
Environmental Compliance, Pollution Prevention, Health and Safety, and Fire Loss and Prevention
Expert has extensive practical knowledge and experience in the field of pollution prevention technologies. He has performed numerous pollution prevention audits internationally resulting in millions of dollars in waste minimization, energy and feedstock material savings for clients. He has worked…
Records Management, Information Governance, International Record Retention, Digital Document Management, Email Management
Records Management; Document Management; Electronic Records: For over 40 years Expert has been involved with records and document management activities as a professional practitioner, consultant, teacher, researcher, and writer. He has extensive experience developing information and records management policies, strategic…
Materials (grain, fertilizer, rock, coal, wood chips, etc.) Handling, Storage and Processing. Facilities, Bins, Silos, Mills and Related Equipment and Processes
Expert has expertise in bulk materials handling, storage, and processing systems particularly in regard to the agricultural industry. He specializes in the structure and systems design of pre-engineered buildings, bins, silos, and bunkers. He has experience in the specification, design,…
Freshwater Impact Assessment, Zebra Mussel Control, Inorganic Contaminants, etc.
Expert has published on, and is currently researching, the chemical, physical, and biological factors that control the duration, frequency, and intensity of fouling. Most of this work is related to fouling in domestic and industrial pipelines and is based on…
Compostable Packaging, Phase I ESA and Sustainability/Environmental Audits, Environmental Chemistry
Expert has extensive experience from his 45 years as a University Professor, Research Biochemist, CEO and Managing Partner. He was the CEO and technical director of an environmental testing laboratory. He is a Senior Scientist and managing partner in an…