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BT235 — Validation Science

3 credits · 3 hours

BT 235 - Validation Science BT 235 - Validation Science This course emphasizes both regulatory and industry requirements for the implementation and maintenance of a validated process, assay, or system. The emphasis will be based on the requirements of the US Food and Drug Administration. The impact of risk and risk mitigation on the validation process assists key elements of the company’s quality system facilitating safe and consistent production of products. This course underscores the significance of the generation and maintenance of appropriate documentation supporting the quality system, enabling successful product launches resulting in the overall success of the company. Course

Prerequisites: BT108

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