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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: 722161 Connecticut, USA

Expert in Microbiology, Biotechnology, Cleanroom Microbiology, Sterilization, etc.

As a consultant, Expert has used his broad-based scientific background to work with a variety of clients. These clients have required expertise in such widely divergent subjects as the production of cellulosic ethanol (requiring a knowledge of basic thermodynamics, enzyme…

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: 718662 Georgia, USA

Expert in Microbiology: Bacteria, Molds/Fungi – Identification, Quality Control, Remediation, Expert Witness

MICROBIOLOGY; BACTERIOLOGY; MYCOLOGY; MICROORGANISM IDENTIFICATION. Expert has expertise in the identification and control of microorganisms including aspects of sterilization, disinfection, and inhibition of microbes. He has extensive background in the application of control mechanisms and chemicals to all environments, including…

Expert ID: 733713 Texas, USA

Expert in Sterility Assurance Expert in terminal sterilization (Ethylene Oxide, Moist Heat, Radiation, Dry Heat) and Aseptic Processing to Medical Device and Pharmaceutical companies.

. Expert is President and Principal Consultant for his consulting company - a consulting LLC. Prior to going into consulting, he was Director of Corporate Quality Technology/ Sterilization Science, for Alcon a Novartis company where he was responsible for sterilization…

Expert ID: 730909 Texas, USA

Expert in Commissioning, Start-up and Validation of Biotechnology and Pharmaceutical Processes

Expert has over 30 years' experience in research, development, QA/QC, technical service, validation, manufacturing and engineering management. All of the above have taken place in the food, pharmaceutical and biotechnology industries. Expert has formal training in microbial physiology, biochemistry and…

Expert ID: 729137 Maryland, USA

Expert in Near Infrared Spectroscopy, Multivariate Analysis, Pharmaceutical Analysis, (GMP)

Expert is an Internationally recognized expert in pharmaceutical analysis, regulatory compliance, laboratory management, design quality, and process analytical technology using spectroscopic methods including near infrared and multivariate analysis. 19 years of industry experience with increasing responsibility and five years of…

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: 722158 Texas, USA

Expert in Contamination Control and Cleanrooms

The relationship between facility cleanliness and product cleanliness, between design criteria and operational conditions is one that even today oftentimes remains a mystery. Particle fallout is the source of visible contamination for contamination sensitive products during storage and assembly. While…

Expert ID: 713979 Colorado, USA

Expert in Microcontamination Control

Expert (prefers Expert ) has been involved with pure, distilled, and demineralized water analysis and methods of purification for over 20 years. With a broad knowledge base and many accomplishments, he has been involved in developing and publishing most of…

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