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Expert ID: 723699 Colorado, USA

Expert in 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…

Expert ID: 733346 Connecticut, USA

Expert in 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,…

Expert ID: 730610 Canada

Expert in 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…

Expert ID: 728217 Maryland, USA

Expert in 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,…

Expert ID: 724419 Arizona, USA

Expert in Quality System & Regulatory Compliance, Life Sciences, Re-Engineering, 21 CFR Part 11

Business system design, business process re-engineering, and business re-engineering are at the core of the expertise she offers her clients. She has designed, written, and implemented business-focused quality systems for start-up companies and well as provided re-engineering support for out…

Expert ID: 723861 Indiana, USA

Expert in Process Automation, including: Control, Computer 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…

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