Masterclass Certificate in Life Sciences Compliance
-- ViewingNowThe Masterclass Certificate in Life Sciences Compliance is a comprehensive course designed to empower professionals with the necessary skills to navigate the complex regulatory landscape of the life sciences industry. This course emphasizes the importance of compliance in maintaining the integrity of research, development, and marketing processes in this sector.
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โข Regulatory Foundations: Understanding FDA, EMA, and Global Regulatory Authorities
โข Quality Management Systems: ISO 13485, ISO 9001, and GxP Compliance
โข Clinical Research Compliance: ICH-GCP, FDA, and EMA Regulations
โข Data Integrity: ALCOA+ Principles and Electronic Records Management
โข Pharmacovigilance: Adverse Event Reporting and Drug Safety Monitoring
โข Medical Devices Compliance: MDD, MDR, and FDA Regulations
โข Clinical Laboratory Compliance: CLIA, CAP, and COLA Regulations
โข Compliance Risk Management: Identification, Assessment, and Mitigation
โข Auditing and Inspections: Preparation, Execution, and Response
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