Global Certificate in FDA Post-Market Surveillance
-- ViewingNowThe Global Certificate in FDA Post-Market Surveillance is a comprehensive course designed to meet the growing industry demand for professionals with expertise in post-market surveillance. This course is crucial for those seeking to gain a deep understanding of the FDA's post-market surveillance requirements and how to comply with them effectively.
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โข Introduction to FDA Post-Market Surveillance: Understanding the FDA's role, post-market surveillance definition, and its importance
โข Regulatory Framework: FDA regulations, guidelines, and laws related to post-market surveillance
โข Pharmacovigilance: Adverse event reporting, signal detection, and risk management in post-market surveillance
โข Medical Device Vigilance: Reporting requirements, incident analysis, and corrective actions
โข Post-Market Clinical Studies: Design, conduct, and analysis of post-market clinical studies
โข Data Management: Data collection, analysis, and reporting in post-market surveillance
โข Inspections and Audits: FDA inspection process, preparing for audits, and corrective actions
โข Risk Communication: Communicating post-market surveillance findings, product recalls, and safety alerts
โข Emerging Trends: Real-world evidence, digital health technologies, and artificial intelligence in post-market surveillance
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