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Operational Streamlining, Organizational Transformation, Program Management, and Technology Integration
Expert has extensive experience in Software Project Management of over 20 years in federal and commercial sectors. He has managed projects involving application development, system integration that required integration of commercial software products (COTS) with application code, software conversion, and…
Cold Process Soapmaking: Developing Countries, Workshop Design to Product Formulation
Safeway UK once threw Expert the challenge of creating concepts for 30 new varieties of soap in 24 hours. These soaps were in their stores within 3 months of that conversation. As the author of 26 books, 'creative origination' is…
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…
Computers, Software, Hard Disk, Bus, Internet, Firmware, Input/Output, Technology Management
Expert is a technical leader in the computer, software and hard disk industry with over thirty years experience; his Ph.D. in Computer Science is from Stanford University. He is an inventor on seven patents and has authored several published technical…
Human Factors/Ergonomics, Systems Safety, Systems Engineering, Industrial Engineering, Design
Expert received his Bachelor of Science degree in Engineering (Astronautical) from Arizona State University in 1969. He next attended Central Missouri State University where he graduated in 1974 with a Master of Science degree with a field of specialization in…
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.…
Quality by Design, Good Laboratory Practices, Intellectual Property Security, ICH and FDA Compliance
As the former CIO of a Fortune 50 product development and commercialization subsidiary, and the executive tasked with building an ISO compliant records management program, Expert has had more than 15 years of experience planning, developing, implementing and then managing…
Professional QA & Regulatory Compliance for Medical Devices, Plastics Process Qualification
Expert has over 30 years of experience as a quality improvement professional, providing technical and managerial quality systems management. His base is a select group of processes within which we maintain current knowledge and process engineering skills. He offers full…
ISO 14001 EMS Implementation, Auditing, and Tailored Training; Integration with GRI Reporting
As a former member of TC 207 and former accredited EMS auditor, as well as an instructor of several accredited ISO 14001 Lead Auditor course providers, he was involved with ISO 14001 since the early 1990's - by way of…