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Medical Devices, Biotech, Aseptic Processing, Engineering, Facilities, and Sterilization
Expert has extensive expertise in all areas of aseptic processing and terminal sterilization of medical devices, human tissue for transplanation processing, microcontamination and controlled environments. He has been involved in clean room projects for Ethicon, Inc., Osteotech, Inc., Manufacturing Automation…
Environmental Client & Project Management: Continuous Emissions Monitoring Systems (CEMS/CERMS)
Expert in Continuous Emissions Monitoring Systems for 30+ years, with experience with multiple instrument installations, testing, and certification for power plants, hazardous waste facilities. He is currently involved in ethylene oxide system installations and commissioning for sterilization plants. Principal Continuous…
Medical Device Design, Simulation and Development
Expert has 25 years of industrial experience in medical devices, consumer products, automotive, robotics, cutting tools and machine tools. He has helped companies to launch 200+ products, published several papers, patents, and chapters in books. His expertise is in medical…
Materials Engineering, Polymers, Metallurgy, Chemistry, Corrosion, and Adhesion Science
Expertise in chemistry, materials science, metals, polymers, corrosion, coatings and packaging. Expert has over 20 years of experience working as a technical consultant in materials engineering, polymers, metallurgy, chemistry, corrosion and adhesion science. She has been an advisor to companies…
Pharmaceutical Science; Preformulating, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation
As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…
Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
Sterile Processing Technology
Expert’s formal training and industrial experience have provided him a solid foundation to design optimal heat sterilization processes for foods, pharmaceuticals, devices, biologics, and equipment. His activities in this field include low-acid canned foods, in-container or terminal heat sterilization of…
Medical Device Engineering
He worked on hazard analysis of medical devices such as biochemical sensors. He worked on packaging processes of medical devices such as implantable catheters. He worked on packaging materials of medical devices such as plastic packaging. He worked on manufacturing…
Pharmaceutics
Expert is a process and chemical engineer with a Bachelor from Univercity Laval in Quebec City. He has more than 15 years experience in engineering, automation, validation of manufacturing equipments, clean utilities, pharmaceutical systems and computer systems (cGMP, GAMP5, CFR-21…
Pressure-Sensitive Tapes: Markets, Materials, Products, Processes, and Equipment
Expert has over 25 years' experience in the pressure-sensitive tape business. His experience includes operations management, and he has held COO and Senior VP titles alike. His total manufacturing experience spans over 40 years. Expert has devoted his career, respectively,…