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Quality Control

course code : QC 001

course hours : 24 hours

PREQ: N/A

Course Description

The course illustrates quality control as regulations and guidelines issued by the international organizations such as World Health Organization WHO, American Food and Drug Organization FDA covering all inputs of the testing procedures to assure the accuracy and precision of the testing results and give the guidance on how to investigate the OOS to save the laboratory resources and working on regulated environment. The course covers the following topics: organization and management, quality management system, control of documentation, records, data-processing equipment, personnel, premises, equipment, instruments and other devices, contracts, reagents, reference substances and reference materials, calibration, verification performance and qualification of equipment, instruments and other devices, traceability, incoming samples, analytical worksheet, validation of analytical procedures, testing, evaluation of test results, certificate of analysis, retained samples and safety.

Learning Outcomes

By the end of the course, the participant will be able to:

  • Apply the international regulation and guidelines
  • Develop the test method validation
  • Implement the test method validation
  • Identify the factors affecting the test results
  • Control factors that affect test results
  • Handle/investigate the out of specification test results
  • Handle the test results and reports

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