Chakradhar Nathuram Bhadade
Senior Engineer @Tata Elxsi
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WORK HISTORY
Senior Engineer @Tata Elxsi
Pune, IN
Biocompatibility | Medical devices | Contact Material List (CML)| Process manufacturing material containing substances identified:| SVHC | RSL Restriction | CMR Cat 1A/1B | the substance of human origin | the substance of animal origin | substance of other biological origins | endocrine disruptors (ED\'s) of toxicological concern | RoHS | & intentionally added nanomaterials | Risk mitigation | Hazards identification | Chemical characterization | Gap analysis | EU MDR ISO 10993 Biocompatibility (medical device) EU MDR ISO 10993: Biological evaluation of medical devices and testing within a risk management process.
EDUCATION
National Institute of Pharmaceutical Education and Research
M.S. Pharm.
Sudhakarrao Naik Institute Of Pharmacy Pusad, Maharashtra
B. Pharm
ABOUT CHAKRADHAR NATHURAM BHADADE
Over 7+ years of experience in Toxicological Risk Assessment and Clinical Safety of COSMETIC, BABY CARE, ENGINEERED products. Margin of Safety Calculations, Raw Material Assessment.Analyzed, collected toxicological and ecotoxicological data from different databases for INCI TP preparation: PCPC, RIFM, CIR, EFSA, FDA.Medical Devices (Biocompatibility), EU-MDR 2017/745, FDA, ISO 10993 series, ISO 14971, ISO 22442, ISO 13485, SCHEER regulation for Phthalates CMR/EDs (BRA) CE marking, 510k submission, IFU, Screening and identification of CMRs/EDs, quantification as per Medical Device Directives, Benefit/Risk analysis.Product Stewardship Regulatory Affairs, Safety Data Sheet (SDS/MSDS), SAP Environment, Health, and Safety Management (EHS), and Label authoring. ECHA, CNESST, GESTIS, PUBCHEM, CHRIPE NITE, CHEMSPIDER IARC, NTP, ACGIH, INCHEM etc. Well versed with REACH, RoHS, SVHCs, TSCA, RSL, EDs, PFAS, POP, vPvB, PBT, QSAR, UN GHS, EU CLP, OSHA. Biodegradability, Nanomaterials, CESIO, California Prop. 65.Well versed with tools: Intelligent Authoring, and SAP tool for SDS, Toxplanet, QSAR tool for toxicology, PML tool for product life cycle management, Chesar tool for chemical safety Report.
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