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Quality Assurance by G Welty

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13

Final implementation

Abstract:

This chapter reviews the scope and impact of FDA regulations for the life sciences industry in general, and for training in particular. Any person who touches the regulated product, or who supervises that person, falls within the scope of the regulations. These persons must be trained on SOPs, insofar as they relate to the employees’ functions, prior to their touching the regulated product. Thus it is critical that the final implementation of the training module includes all these employees. Next, a widely used approach to ensuring that employees are trained before they touch the regulated product is critically examined. A supervisor is required by SOP to ensure all necessary training and qualification requirements ...

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