QualityManagement, Standardization, and Regulatory Compliance
Reliable and accurate laboratory results are the cornerstone of effective clinical decision-making, making quality management, standardization, and regulatory compliance essential in clinical chemistry. This session focuses on best practices for ensuring analytical accuracy, reproducibility, and consistency across laboratories, covering topics such as method validation, internal and external quality control, and proficiency testing. Participants will explore international standards, accreditation requirements, and regulatory frameworks that guide laboratory operations and ensure patient safety. The session also highlights strategies for harmonizing assays, implementing standard operating procedures, and addressing pre-analytical, analytical, and post-analytical challenges in diverse clinical settings. Additionally, the role of laboratory information systems, automation, and data management in supporting quality assurance and regulatory compliance will be discussed. By emphasizing the integration of quality management systems with modern diagnostic technologies, this session provides participants with practical insights into maintaining excellence in laboratory practice, supporting reliable early disease detection, and meeting global standards in clinical chemistry.
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