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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…
Industrial Woodworking Machinery, Saw Safety, Accident Investigation, Expert Witness
Expert has 33 years of experience in the industrial woodworking machinery arena. His expertise has been in machine design, machine manufacturing and management. He is proficient in each area and demonstrates a wide range of technical knowledge and management skills.…
Railroad Operations, Project Management, Market Analysis and Business Development
Expert has over 40 years of experience in the railroad and transportation industry. After serving in top management positions in Class I and Short Line railroads for many years, he founded Employer in 1983. His vast expertise has included involvement…
Oil Terminal Operations Troubleshooting, Contract Negotiation, Mechanical Issues, Oil Inventory Loss
He is a hands-on manager in chemical and fuel oil terminals. He has rebuilt and maintained terminals, done inventory control, handled union negotiations, safety procedures, pollution control and prevention. He has been a peer manager, construction manager, and purchasing agent.…
Semiconductor Post Etch Residue Cleaning, Post CMP Cleaning and CMP Slurries, Photoinitiator Process
Expert managed the initial stages for the ITX photoinitiator process as an applied organic chemist. He designed research parameters and the design of experiments to define process parameters and process economics. This product had annual sales of $3+ MM. Interacted…
SARS-CoV-2 Coronavirus, COVID-19, Sanitization Procedures, Forensic Science, Toxicology, DNA Analysis, Food Poisoning, and Toxic Torts
Expert is a Full Professor of Toxicology and has received grants from NIH in the area of Applied Toxicology. Expert has received grants from NIH in the area of Biotoxicology. Part of his research entails molecular analysis of toxins. Expert…
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…
Validation of Sterilization Processes and USP/AAMI Microbiology, Cleanroom Practices, Aseptics, etc.
Expert has years of experience in validating EO sterilization systems per ISO 11135, Gamma sterilization systems per ISO 11137, and Steam sterilization systems per ISO 11134/17665. This would also include troubleshooting and cycle development issues. He has worked with large…
Surface Science, Polymers, Textiles, Testing Materials, Plastics, Physical Chemistry, Pharmaceutical
Expert worked for three years as the Director of RD&E for the chemical products division of Waters Inc. In addition to the direction of the research in chromatographic media he was co-inventor of 7 patents for water-wettable extraction media and…
Optical Instruments, Inertial Instruments, Laser and Fiber Optic Gyros, Thin Film Coating
Over 41 years of experience in fiber optics sensors and fiber optic devices for telecommunication networks. The experience includes all phases of product development from conceptual design to prototyping, design-to-cost, production planning, and transition to production. Has nine patents and…