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Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…
Lubricant Processing Technology, Petroleum Procurement & Products, R&D and Value Addition
Expert has long research & developmemnt experience in lube stocks refining, both through conventional and hydroprocessing routes, base stocks characterization, blending & additive response studies and upgradation of older lube manufacturing plants to make base oils as per API groups.…
Manufacturing, Process Development, Machining, Cutting Tools, Innovation, Training
Expert has extensive knowledge and experience in the applications of metal cutting and cutting tools and in research in manufacturing technologies. He has worked and taught for more than 38 years on R&D projects including topics such as: manufacturing process…
Flexible Packaging Materials; Film Extrusion, Extrusion Lamination, Food Packaging, and Food Packaging Safety
Fellow, Society of Plastics Engineers Inductee, Packaging Hall of Fame Expert has spent over 35 years in the development and application of functional materials for a variety of packaging and non-packaging applications (process and platforms). He has developed various multi-layered…
Patent Infringement, Implants, Medical Devices, Surgical Devices, Surgical Implants, FDA
Expert has expertise in certain medical devices and surgical devices. He also has expertise in certain medical implants and surgical implants.
Food & Drug Administration Rules, Policies, Procedures for Medical Devices and Pharmaceuticals
Expert is an FDA compliance expert with 28 years experience in the field. He served the U.S. Food and Drug Administration as an Investigator concentrating in compliance for pharmaceuticals and medical devices as well as pre-market development of drugs and…
Pharmaceutical Quality Assurance, Quality Control, Supplier Selection and Supplier Quality
Expert has extensive expertise in GMP matters in the pharmaceutical and medical device industries. During his 20 years in industry, he devised, managed and led programs to assure compliance to drug GMPs, GLPs and GCPs. Key areas of expertise included…
Logistics, Procurement, Supply Chain Management
Expert has applied his Procurement & Supply Chain Management background coupled with his Knowledge of Chemistry/Bio-chemistry to create robust operating plans in various sectors .This was further enhanced by the training acquired on the SAP business enterprise Resource planning tool…
Clinical Diagnostics, Immunoassay Product Development, Clinical Toxicology
Expert has two major areas of Expertise: 1) He has been involved in all aspects of In Vitro Diagnostic Immunoasasy and Clinical Chemistry Product Development Including Laboratory Research and Development, Transfer to Manufacturing, Documentation to meet QSR including Design History,…
Life Science, Biotech, Pharmaceuticals: Research and Development, Smart Manufacturing/ Supply Chain, and Market Launch/ Commercialization
Expert has over 20 years of experience in strategic innovation, system building, and delivering value solutions for global markets. His focus is on building infrastructure synergies between science, technology, and finance. As a Strategic Advisor, he has experience with: •…