Global Certificate in Biomedical Device Data Integrity
-- ViewingNowThe Global Certificate in Biomedical Device Data Integrity course is a comprehensive program designed to equip learners with critical skills in ensuring data integrity in biomedical devices. This course is of paramount importance in the rapidly evolving medical device industry, where data integrity is a key focus area for regulatory compliance and patient safety.
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โข Data Integrity Fundamentals: Understanding Data Integrity, Importance of Data Integrity in Biomedical Devices, Key Concepts and Definitions
โข Regulatory Landscape: FDA, EU MDR, MDSAP, ISO 13485, GMP, GDP, Data Integrity Guidelines
โข Data Lifecycle Management: Data Creation, Data Storage, Data Transmission, Data Archiving, Data Retention, Data Destruction
โข Risk Management: Risk Identification, Risk Analysis, Risk Evaluation, Risk Control, Risk Review
โข Data Security: Access Control, Network Security, Physical Security, Data Encryption, Data Backup and Recovery
โข Change Management: Change Request, Change Evaluation, Change Implementation, Change Review, Change Closure
โข Quality Management System: QMS Principles, QMS Implementation, QMS Audit and Continuous Improvement
โข Data Integrity Validation: Validation Planning, Functional Requirements, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification
โข Data Integrity Incident Management: Incident Detection, Incident Reporting, Incident Investigation, Incident Response, Incident Root Cause Analysis, Incident Follow-up
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