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Expert ID: 735231 Brazil

Expert in Process Improvement Consultant and Virtual Process Validation Through Discrete Event Simulation

With more than 25 years of experience working in industries of different segments (metal mechanic, polymers, rubber, automotive and machining) combined to his enthusiasm for lean process Expert has specialized himself planning and implementing new processes and performing process improvement…

Expert ID: 731857 Illinois, USA

Expert in Sterile Process Validation, Microbiology, Steam Sterilization, Aseptic Filling, Rapid Micro Methods

Expert has over 25 years experience in various aseptic of sterile process validation. She has worked for Baxter, Fujisawa (now Astellas), Jordan Pharmaceuticals, Vectech Pharmaceutical Consultants and Excellent Pharma Consulting. This encompasses steam sterilization, aseptic filling, process validation, development of…

Expert ID: 731170 New Jersey, USA

Expert in Statistics (Pharmaceuticals (CMC): Design of Experiments, Process Validation, Stability)

After receiving a Expert in statistics, expert has worked in the pharmaceutical industry for over 30 years as a non-clinical statistician applying statistical methodologies, performing data analysis, and interpreting results with scientists in research and development. He collaborated with scientists…

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: 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…

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: 722341 New Jersey, USA

Expert in Aseptic Process Design, Airflow Visualization, HACCP, PAI Preparation, Cleaning Validation

Expert has performed validation of aseptic processes including technologies such as blow-fill-seal, high-speed automated liquid and powder filling lines, lyophilization, barrier and isolation technology, and bulk pharmaceutical and biological processes. Expert has developed an airflow visualization procedure to assist the…

Expert ID: 107894 Ohio, USA

Expert in Sterilization; Food & Drug Product, Packaging & Process Development; HACCP & Validation

Expert is a nationally recognized expert in aseptic, retort and autoclave, thermal processing and associated packaging of foods and drugs. He is well networked with the FDA food regulatory agency technical staff, academia, other process authorities, and research consortia. He…

Expert ID: 733783 Missouri, USA

Expert in Equipment Validation

Experienced pharmaceutical process engineer with demonstrated ability in managing, supporting, and formulating in a dynamic environment. EQUIPMENT EXPERIENCE  Ackley Imprinter  Glatt - GPCG-1, GPCG Pro-5, VG Pro 65, Midi Glatt, VG-25, Glatt SKS-100 valves.  Korsch - XL400WIP,…

Expert ID: 735112 Puerto Rico, USA

Expert in Coatings; Powder, liquid, Electrocoating and metal finishing process

As a Continue Improvement Manager (holding a Managerial position company deems fit), Expert is offering his engineering education, managerial experience, training in Lean manufacturing principles and Kaizen facilitation expertise to Operations, Business Unit or Production Area at a Manufacturing, Pharmaceutical,…

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