Thomas Feinberg

Managing Director @Feinberg Norwood & Associates

Chapel Hill, NC, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Mar 2019 — Present

Managing Director @Feinberg Norwood & Associates

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Science-based consulting practice focused on helping clients find solutions for difficult analytical chemistry problems such as Extractables and Leachables. Experienced with Technical Staff Organizational Development and Breakthrough Lean initiatives. Provider of strategies for compliance with future world-wide regulatory initiatives.Key Services CMC Documentation Review Analytical Development Program Management Quality Control / Quality Assurance / Regulatory Compliance Support Extractables and Leachables Programs Contract Analytical Service Vendor Management Lean Laboratory Implementation

EDUCATION

N/A

Cornell University

Bachelor's Degree

N/A

University of North Carolina at Chapel Hill

Doctor of Philosophy (Ph.D.)

SKILLS

U.s. Food and Drug Administration (Fda)Gc-MsGlpUspExperimental DesignSituational LeadershipCapaPolymer CharacterizationBiotechnologyAnalytical ChemistryContinuous ImprovementPackagingManagementGood Laboratory Practice (Glp)Scientific WritingCorrective and Preventive Action (Capa)GmpValidationMass SpectrometryStrategic PlanningLc-MsLife SciencesChromatographyHplcSpectroscopyEnvironmental AnalysisStandard Operating Procedure (Sop)Analytical Method ValidationU.s. Title 21 Cfr Part 11 RegulationCgmpPharmaceutical IndustrySopFda21 Cfr Part 11ValidationsBusiness AnalyticsOperational ExcellenceLean SigmaDrug DevelopmentPhysical Chemistry

ABOUT THOMAS FEINBERG

Results-oriented Research and Development executive with particular emphasis on Analytical Development and recognized expertise in Extractables & LeachablesSpecialties CMC Documentation Review Analytical Method Remediation / Gap Analyses Analytical Method Development / Validation OOS Investigation Documentation / Root Cause Analyses Form 483 Response Preparation / Management Technology Assessments / Due Diligence Audit Support Contract Analytical Service Vendor Management / RFP Development Standard Operating Procedures / 21CFR 211 Compliance Computer System Validation / 21CFR Part 11 Compliance Breakthrough Lean Program Development Lean Sigma Project Sponsorship Laboratory and Quality Process Mapping Technical Staff Development Technical Staff Organizational Design and Implementation

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Thomas Feinberg — Managing Director at Feinberg Norwood & Associates in Chapel Hill, NC, US | Unifers