
Ashish Yadav
Specialties: • FDA Regulatory Standards: 510(k), PMA, Biocompatibility (ISO10993), Common Technical Document (CTD/eCTD), Labeling, Post-Market Surveillance, domestic... | Newport Coast, Newport Coast, United States
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Ashish Yadav’s Location Newport Coast, Newport Coast, United States
Ashish Yadav’s Expertise Specialties: • FDA Regulatory Standards: 510(k), PMA, Biocompatibility (ISO10993), Common Technical Document (CTD/eCTD), Labeling, Post-Market Surveillance, domestic & international regulatory affairs policies and regulations like Canada, EU and China, Complaint Handling and MDR. • Quality Control and Assurance: 21 CFR Part 11, 210, 211, 803, 806, 807, 814, 820, WHO & ICH regulations, ISO 13485, ISO 14971, ISO 17025, OSHA, cGMPs, GCLP, CAPA, MDD, Design Controls, Statistical Process Control, Packaging, Validation & Verification, Sterilization (ISO 11135), Six Sigma methodologies like flowcharting, FTA, 5-Whys, Cause and Effect Diagram, DMAIC, FMEA, FMECA and Root Cause Analysis. • Computer Skills: MATLAB, SIMULINK, MATHEMATICA, MS Excel, Word, Access, Project, Documentum, Adobe, PowerPoint, Outlook, Minitab, Visio, C, C++, Windows XP/Vista/Windows7/Macintosh. Also proficient in handling PCR, Cell Culturing, Chromatography Techniques, Electrophoresis, ELISA, Western Blotting, SDS PAGE, Gel-Filtration, Spectophotometry, Autoclaving, Fermenter Processing.
Ashish Yadav’s Current Industry No Industry Available
Ashish
Yadav’s Prior Industry
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