Executive Development Programme in Molecular Diagnostics and Regulatory Affairs
-- ViewingNowThe Executive Development Programme in Molecular Diagnostics and Regulatory Affairs is a certificate course designed to provide learners with essential skills in the rapidly evolving field of molecular diagnostics. This programme emphasizes the importance of regulatory affairs, ensuring that learners understand the compliance requirements and standards necessary to succeed in this industry.
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โข Introduction to Molecular Diagnostics: Principles, Technologies, and Applications
โข Molecular Biology for Molecular Diagnostics: DNA, RNA, and Protein Analysis
โข Clinical Applications of Molecular Diagnostics: Infectious Diseases, Oncology, and Genetic Disorders
โข Next-Generation Sequencing: Technologies, Data Analysis, and Clinical Applications
โข Point-of-Care Molecular Diagnostics: Devices, Assays, and Regulatory Considerations
โข Quality Management in Molecular Diagnostics: Accreditation, Proficiency Testing, and Quality Control
โข Regulatory Affairs for Molecular Diagnostics: Global Regulations, Compliance, and Quality Systems
โข Clinical Trials and Validation Studies: Design, Execution, and Reporting
โข Medical Device Regulations and Quality Systems: ISO 13485, FDA, and EU MDR
โข Risk Management in Molecular Diagnostics and Regulatory Affairs: ISO 14971 and FMEA
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