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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⢠Regulatory Foundations: Understanding FDA, EMA, and Global Regulatory Authorities
⢠Quality Management Systems: ISO 13485, ISO 9001, and GxP Compliance
⢠Clinical Research Compliance: ICH-GCP, FDA, and EMA Regulations
⢠Data Integrity: ALCOA+ Principles and Electronic Records Management
⢠Pharmacovigilance: Adverse Event Reporting and Drug Safety Monitoring
⢠Medical Devices Compliance: MDD, MDR, and FDA Regulations
⢠Clinical Laboratory Compliance: CLIA, CAP, and COLA Regulations
⢠Compliance Risk Management: Identification, Assessment, and Mitigation
⢠Auditing and Inspections: Preparation, Execution, and Response
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