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Development and Assurance of High-Assurance / Safety-Critical Software & Embedded Systems
Expert has substantial experience with software safety and reliability. Most of his career has been spent working with high-assurance systems and safety-critical software. He has developed software for commercial aviation systems, for medical devices, and for industrial controls and safety…
Medical/Hospital Equipment: Markets, Unmet Needs, Concept, Design, IP, Automation, Manufacturing
Biomedical Devices range from simple items we use as consumers to complex instruments controlled by proficiently trained professionals. Expert's involvement and experience has been in the development of capital equipment that often included one or more disposables, were used in…
Software Configuration Management, Python, Perforce, SYNERGY, JAVA
He has Implementation knowledge of SCM practice for major Projects. He has Knowledge of Working on Multisite Environment. He has Implementation knowledge of Replication & Integration of Source Codes. He has Knowledge of Perforce, CVS, Sub Version & Rational Clearcase…
Pharmaceutical Engineering Maintenance, Calibration, Training, Safety System Implementation & Audits
As he has been the Head of Facility & Chief Engineer & Administration of world class standards,he was overall in charge of Facility Management of Medicorp’s as well as Unit I & VI. Of Aurobindo’s world class manufacturing facilities complying…
Knowledge Visualization, Technology Integration, Open Standards, etc.
Expert has thirty years professional experience in private, consulting and government organizations. Throughout his career, he has focused on helping organizations develop business rules, manage knowledge, and develop more intuitive scientific, technical and business visualizations to better control and understand…
Medical Device Design and Manufacture
Expert has over 25 years experience in the conception, design, and manufacture of medical devices. Experience ranges from high volume disposables to low volume implantables. Beginning as a manufacturing engineer responsible for all facets of device development and manufacture Expert…
Software Development, Technical Writing, and Project Management
Expert has experience with Software development tools for embedded systems engineers, marketing, project management, and technical publishing. The technical publications Expert develops show three essential qualities: close attention to the needs of the audience, correct content, and a clean look…
Pharmaceutical Quality Assurance
He possess thorough knowledge of GMP / GLP regulations like US FDA, WHO GMP, ICH, MHRA, ANVISA, requirements of cGMP documents (SOP’s/ Change controls/ Deviations) as per various regulatory agencies. He had actively participated in various international regulatory inspections (USFDA…
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…
Ceramic, Graphite & Composites. Forensic engineering in glass & ceramic.
He has a comprehensive ceramic component manufacturing experience. This encompasses everything from ceramic materials and process development, production scale up and running of a production operation, as well as marketing and sales, excelling in all areas. He has worked in…