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Medical Device Regulatory Support, Medical Device Registration, etc.
Expert is a Regulatory and Quality Consultant with strong team building skills for high technology corporations. A hands-on career of increasing leadership positions with a broad range of responsibilities in manufacturing, regulatory affairs and new product introductions. A committed professional…
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…
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…
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…
Software Application Development, IT Compliance, Pharmaceuticals, Large systems Release Engineering
Expert has designed a number of customer relationship management solutions (CRM) using different platforms such as salesforce.com, salespharma.net. Also, in his capacity as a director of technology for a number of companies he has been involved in the technical evaluation,…
Adhesives for Medical Device, Biotech, Pharmaceuticals, Aerospace, Materials Science, QA, QC
With a PhD in organic chemistry expert has spent over 25 years developing adhesives, resins and advanced composites for a variety of applications. He started at the bench chemist level and worked his way up into R&D management. Some of…
Product Development High Stakes Problem Solving – Expert in Design of Experiments
He began developing and seeing results from his Design Of Experiments techniques at the General Motors Research Labs in 1986. He has refined and tested them in various environments, including automotive, aerospace instrumentation, armament technology and medical products in roles…
Medical Device Design and Manufacturing, Measurement Systems, Embedded Systems, etc.
Expert has extensive experience with biomedical imaging and medical diagnostic imaging as listed below: • Cell Counting – Used segmentation, clustering and classification techniques to count cells in fluorescent and scatter images. • DR Bone Densitometry – Developed automatic and…
Complete vertical product integration: EMC/EMI, Wireless, IoT, Audio/Video, Automotive, Imaging, Hardware, Firmware, Cloud
Expert has expertise in the design of biomedical imaging products, providing patient safety and comfort regarding ISO and FDA requirements. He is an Adjunct Professor teaching on biomedical instrumentation including cardiac, ultrasonic equipment, pressure and flow measurements. He has magnetic…