Tarun Chandra
CEO, EmpiriQA LLC
- Role
- Consultant at Thermo Fisher Scientific
- Location
- Chicago, IL, US
- LinkedIn followers
- 500 followers
About Tarun Chandra
EmpiriQA LLC is a medical devices, diagnostics and biotechnology consulting company. Using a combination of technical expertise, statistical inference, analytical methodology and persuasive information presentation, EmpiriQA empowers its client decision makers, management, scientists and engineers to meet aggressive project commitments in a cost-effective way.Consulting Expertise:New Product DevelopmentQuality systems and Design ControlsApplied Statistics for Medical Device, IVD, CDx, LDT, Pharmaceutical and Biotechnology productsProcess, Test Method, Software and Equipment Validations for FDA-regulated companiesComputer and Mathematical Modeling and SimulationsCost-effectiveness and Health Economics analysisISO-13485 and QSR ComplianceQA/QC, Specification Setting, DOE, Analytical Performance assessment, Process capabilityDesign Control and CAPAPMA/510(K)/IND/NDA & CE Regulatory Submission supportProduct and Process Design and OptimizationImmunodiagnostic, Molecular, Next Generation Sequencing (NGS) Assay developmentManufacturing OperationsSystems IntegrationBiomedical Engineering
Experience
Consultant
Jan 2009 — Present
qPCR and NGS CDx assay and instrument system development and validation
Education
Indian Institute of Technology, Delhi
B.Tech, Chemical Engineering
1980 — 1985
University of Illinois Chicago
M.S. & Ph.D, Chemical Engineering
1985 — 1992
Skills
- Sop Development
- Quality System
- V&V
- Statistics
- Design of Experiments
- Medical Devices
- Capa
- Gmp
- Validation
- Cross-Functional Team Leadership
- Pharmaceutical Industry
- Sop
- Fda
- Life Sciences
- Commercialization
- R&D
- Iso 13485
- Change Control
- Biotechnology
- Lifesciences
- Product Development
- Technology Transfer
- Design Control
- Specifications
- Glp
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