GXP

Developing a Bulletproof GXP Training Process from the Ground Up—A Case Study

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. THE PEOPLE 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 Beverly...

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