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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…
Medical Device Product Development; Machine Design; Biomedical Engineering
Medical device product development engineer. He performed research on adding an antimicrobial agent to a silicone rubber medical device molded using LIM. The research included materials, methods of molding, color changes, and effects on biocompatibility. His library contains many materials…
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…
FDA Compliance, Project Management, New Product Development, Validation, Cultural Transformation
Expert has audited many cGMP operations. A good audit starts with a good plan. Before starting an on-site audit, he reviews past audits. He notes indications of possible problem areas and items, if any, that were identified for corrective action…
Occupational Safety, Industrial Hygiene, and Ergonomics
Twenty years of experience enables Expert to address the widest variety of occupational safety program issues. He is familiar with the federal regulations as well as the requirements in each of the dozen or so states which mandate written occupational…
Commercialization of Scientific Devices, Inventions, Scientific Management Consulting, etc.
Expert has used his experience and knowledge of biochemistry and biophysical measurement to create tools for measurement of clinically significant targets for the biomedical industry. He has developed Drugs of Abuse and many other assays, supported the development of complex…
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…
Root Cause Analysis, Problem Solving, SPC, Design of Experiments, Six Sigma
Expert has been a member of ASQ for 20 years. He has been a senior member of ASQ for 10 years. He has served as the Examining Chair for the Indianapolis Section of ASQ for 15 years. Through his work…