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RA/QA Training for the Life Sciences Industry

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Medical Device RA/QA

New! Inspection and Audit Readiness Training for Medical Device Manufacturers

Topic Medical Device QMS Auditing

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New! QMS Training for Medical Devices: ISO 13485:2016 and FDA QMSR

Topic Medical Device RA/QA Training

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ISO 13485 Lead Auditor Training Course

Topic Medical Device RA/QA Training

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New! Transition from the FDA’s Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) - DaySmart Series

Topic Medical Device RA/QA Training

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ISO 14971 Medical Device Risk Management and Analysis Training

Topic Medical Device RA/QA Training

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Medical Device QMS Overview Training

Topic Medical Device RA/QA Training

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Medical Device CAPA and Root Cause Investigation Training

Topic Medical Device RA/QA Training

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Medical Device Design Control Training

Topic Medical Device RA/QA Training

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EU MDR Auditor Training Course for Europe’s Medical Device Regulation (2017/745)

Topic Medical Device RA/QA Training

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EU MDR Training for the European Medical Device Regulation (2017/745)

Topic Medical Device RA/QA Training

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ISO 13485 Internal Auditor Training Class

Topic Medical Device RA/QA Training

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Medical Device Single Audit Program (MDSAP) Internal Auditor Training

Topic Medical Device RA/QA Training

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Medical Device Complaint Handling, Event Reporting, and Recall Management Training

Topic Medical Device RA/QA Training

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EU MDR CER (Clinical Evaluation Report) Training for Medical Devices

Topic Medical Device RA/QA Training

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Medical Device Software Development Life Cycle (SDLC) and IEC 62304 Training

Topic Medical Device RA/QA Training

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Medical Device Supplier and Subcontractor Quality Management Training

Topic Medical Device RA/QA Training

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Performance-Based Auditing for Medical Devices - A Tool for FDA’s Case for Quality

Topic Medical Device RA/QA Training

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Understanding FDA’s Medical Device Quality System Regulation

Topic Medical Device RA/QA Training

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New! Inspection and Audit Readiness Training for Medical Device Manufacturers

Topic Medical Device RA/QA Training

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Medical Device Process Validation Training Course: FDA and ISO 13485 Requirements

Topic Medical Device RA/QA Training

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Medical Device Production and QMS Software Validation Training

Topic Medical Device RA/QA Training

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ISO 13485 Overview Training for Medical Device and IVD Manufacturers

Topic Medical Device RA/QA Training

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ISO 9001 Internal Auditor Training

Topic Medical Device RA/QA Training

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Combination Device Supplier Management Training

Topic Medical Device RA/QA Training

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EU IVDR Auditor Training Class (2017/746)

Topic Medical Device RA/QA Training

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Medical Device Cybersecurity Risk Management, Regulations and Standards Training

Topic Medical Device RA/QA Training

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EU In Vitro Diagnostic Regulation Overview Training (IVDR 2017/746)

Topic Medical Device RA/QA Training

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Medical Device Postmarket Surveillance (PMS) Training

Topic Medical Device RA/QA Training

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FDA and EU Medical Device Software Regulations and Standards Training

Topic Medical Device RA/QA Training

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FDA and EU Medical Device Labeling Requirements Training

Topic Medical Device RA/QA Training

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Inspection and Audit Readiness Training for Medical Device Manufacturers

Topic Medical Device RA/QA Training

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Inspection and Audit Readiness Training for Medical Device Manufacturers

Topic Medical Device RA/QA Training

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FDA and EU Medical Device Classification and Regulatory Pathway Training

Topic Medical Device RA/QA Training

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ISO 14971 and Risk Management Training for Combination Drug-Device-Biologic Products

Topic Medical Device RA/QA Training

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Medical Device Single Audit Program (MDSAP) Training

Topic Medical Device RA/QA Training

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FDA 21 CFR Part 11 Training: Pharmaceutical Data Integrity, ALCOA+, and Electronic Records

Topic Medical Device RA/QA Training

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FDA Part 11 Compliance and Medical Device Data Integrity Training

Topic Medical Device RA/QA Training

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ISO 9001:2015 Lead Auditor Training Course

Topic Medical Device RA/QA Training

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Lean Six Sigma Champion Training Course

Topic Medical Device RA/QA Training

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Lean Six Sigma Champion Training Course

Topic Medical Device RA/QA Training

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US FDA and EU Regulatory Requirements Training for Combination Products

Topic Medical Device RA/QA Training

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Design Control Training for Drug-Device and Other Combination Products

Topic Medical Device RA/QA Training

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Medical Device SOP Writing and Process Mapping Training

Topic Medical Device RA/QA Training

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FDA GMP Inspection and For Cause Audit Training for Combination Products

Topic Medical Device RA/QA Training

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Lean Six Sigma Black Belt Certification Training

Topic Medical Device RA/QA Training

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Lean Six Sigma Black Belt Certification Training

Topic Medical Device RA/QA Training

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Lean Six Sigma Master Black Belt Certification Training Course

Topic Medical Device RA/QA Training

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Lean Six Sigma Master Black Belt Certification Training Course

Topic Medical Device RA/QA Training

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Training on How to Conduct a Remote Medical Device QMS Audit

Topic Medical Device RA/QA Training

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Root Cause Analysis for Combination Products and Drug Delivery Systems

Topic Medical Device RA/QA Training

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Root Cause Analysis for Combination Products and Drug Delivery Systems

Topic Medical Device RA/QA Training

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Medical Device Human Factors Usability and IEC 62366 Training

Topic Medical Device RA/QA Training

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Drug Delivery System Human Factors and Usability Requirements Training

Topic Medical Device RA/QA Training

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Pharmaceutical RA/QA

New! FDA GMP Inspection and For Cause Audit Training for Combination Products

Topic Regulatory Compliance for Pharmaceuticals

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New! Root Cause Analysis for Combination Products and Drug Delivery Systems

Topic Regulatory Compliance for Pharmaceuticals

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New! Investigations Into Deviations and Out-of-Specification (OOS) Test Results in Pharmaceutical Manufacturing

Topic Regulatory Compliance for Pharmaceuticals

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Pharmaceutical Process Validation Training

Topic Regulatory Compliance for Pharmaceuticals

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Drug Delivery System Human Factors and Usability Requirements Training

Topic Regulatory Compliance for Pharmaceuticals

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Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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