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Quality Assurance II

PQA811

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PQA811 - Quality Assurance II

Prerequisites:

PQA711

This course describes the role and responsibilities of the Quality Assurance department in a pharmaceutical company. It focuses on: 1) the design of a proper quality control/assurance system to ensure the manufacturing of safe products and satisfy regulatory authorities. All systems, from cleaning to component testing, from product assay to product release are geared to provide the manufacturer documented quality checkpoints on the product; 2) management of the quality assurance systems to provide sufficient and adequate records on all testing, distribution and all other procedures that must be in place.


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