The following is a fictitious scenario (although based on real cases the authors have observed) following one company through the development of a bulletproof GXP training process. The principles identified would apply to manufacturers of medical devices, blood products, biologics, dietary supplements, cosmetics, and foods.
Lawrence Townsend: Vice president of operations
Robert Ginelli: GXP Consultant
Angela Richardson: Director of quality
Bonnie Leonard: Personnel assistant
Manoj Gupta: Manufacturing supervisor
Charles Hasson: Controller
Guadalupe Rodriguez: Second shift supervisor
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This is the first in a series of quizzes testing your knowledge of terminology in the areas of validation and compliance. This week's quiz will focus on cleaning validation and cleaning good manufacturing practices.
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