Initial scientific training, initial experience in bioindustries, chemistry, pharmacy, or equivalent in conducting or supervising manufacturing or quality control operations in the health industry.
Course modules
about 2 hours
Validation of analytical methods
This activity covers the lifecycle of analytical method validation, from the identification of needs to routine use, detailing the basic concepts, types of analytical tests, and performance characteristics that ensure reliable and accurate results.
This activity presents the development and implementation of a method validation protocol, including acceptance criteria and deviation management, through practical examples illustrating a validation strategy that ensures method robustness.
This activity focuses on data integrity in quality control, addressing ALCOA+ principles, metadata management, and the application of rules to ensure complete, consistent, and reliable data throughout their lifecycle.
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