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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…
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…
Medical Device Regulatory Affairs: CE (Canada) and FDA
Expert has 25 years' experience in FDA, TGA, CE, and Health Canada product approvals for medical devices and combination devices. He has experience writing CER, CE applications, FDA applications, TGA and Health Canada applications. He has performed PMS, PMCF, recall,…
Sterile Processing, Team Building, Department Collaboration, Standardizing, PI, and Change Management
Expert is a diversely skilled Sterile Processing executive with over 34 year’s medical experience. Among other achievements, she has established department SOP -- and implemented, demonstrated and mastered LEAN processes. She eradicated IUSS -- formerly flash sterilization. She has also:…
GMP Compliance EPCMV of BioPharmaceutical Process, Clean Utilities, Systems, Facilities Engineering
He is a Health Canada Expert (in 2007) and a Senior BioProcess Engineer & Project Manager Consultant; He acquired more than 21 years’ experience with various BioPharma Industries & Consulting companies (SNC Lavalin Pharma), where more than 50 projects were…
Medical Device Sterilization, Medical Device QA, GMP Audit, Supplier Audit, SOP\’s
Expert, Consulting Principal, is highly regarded in the medical device and sterilization industries. Areas of expertise include: medical device sterilization (Radiation and EO), quality systems development and assessment, sterilization management, medical device regulations, supplier auditing, internal auditing, nonconformity investigation and…
QC/QA, Sterility Assurance, Aseptic, Pharmaceutical, Biotech, Device Manufacturing & Testing
Environmental Monitoring Operations, EM Trends Reports, EM Remediation and Investigation. Cleanroom Contamination Control Practices, Behaviors, Personnel, Gowning, Cleanroom Traffic Guidelines, Process/Personnel and Product Flows. Microbiology Release Testing-Bioburden, Sterility Test, Growth Promotion, Materials Control, Microbial Identification, Bacteria Endotoxin, Biological Indicators Testing,…
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…
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…
Adhesives for Medical Device, Biotech, Pharmaceuticals, Aerospace, Materials Science, QA, QC
With a PhD in organic chemistry expert has spent over 25 years developing adhesives, resins and advanced composites for a variety of applications. He started at the bench chemist level and worked his way up into R&D management. Some of…