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Expert ID: 727870 United Kingdom

Expert in Implementation and maintenance of Quality Management Systems, Pharmaceutical GMP for Excipients

Expert has applied his scientific background in various companies over the past 25 years. He has set up and managed spectrophotometric and electron microscopy laboratories - choosing and installing (including EDX and WDX analysers), undertaking research and developing a range…

Expert ID: 724218 California, USA

Expert in Medical Device Software, Medical Device Software Engineering, FDA Compliance, FDA 501K and PMAs for Software

Expert has wide range of extensive hands on experience developing and manufacturing medical devices. Over the last twenty plus years he has successfully deployed several medical devices in the cardiovascular, opthalmic, and diagnostic industries. His responsibilities have covered the gamut…

Expert ID: 723348 Costa Rica

Expert in Chemical Engineering, Trouble Shooting of Chemical Plants, Fats & Oils, Biodiesel, Biofuels

Expert is a chemical engineer with master’s degree in Business Management. Expert has over 22 years of experience in large Oleo chemical oil refineries, petrochemicals and fertilizer industries in Asian countries. He has been involved in successful troubleshooting of various…

Expert ID: 722994 California, USA

Expert in Quality Management Systems and Engineering Ceramics

Expert W. Expert has extensive experience with implementing and managing the ISO 9000 series of quality standards. He became an ISO Lead Auditor at Corning, Inc. He used his knowledge to implement and pass the ISO 9000 quality systems at…

Expert ID: 722568 Delaware, USA

Expert in Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms

As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into human clinical trials under IND controls. Four of…

Expert ID: 717458 New Jersey, USA

Expert in Laboratory Management; Quality Assurance/Control

Expert has demonstrated expertise with the design, development, and start-up of laboratory facilities. These facilities have been used for analytical testing, physical characterization, environmental sample conditioning, and drug stability testing. He has specified and implemented purified water systems, sample conditioning…

Expert ID: 108065 Washington, USA

Expert in Software Process Standards

Expert is considered an expert on the standards required to write software for the Web. He recently co-authored the book: A Guide to Standards and Specifications for Designing Web Software. He has published three books on software engineering standards and…

Expert ID: 713381 Minnesota, USA

Expert in Medical Technology

A significant portion of Expert's current activities include maintaining awareness and working knowledge of regulations that impact medical device manufacturers. She has specific experience with new medical device submissions, including combination products. Expert is proficient in total quality systems requirements…

Expert ID: 107971 Illinois, USA

Expert in Quality Assurance Systems and Training

Ms. Expert has worked with numerous large and small organizations to establish and implement TQM processes. This process starts with an internal evaluation, then continues with policy and mission statements and the establishment of a steering committee to draw up…

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