Inside FDA
Inside the FDA is a thoughtful, balanced, and well-researched look inside the controversial and troubled Food and Drug Administration. Author Fran Hawthorne is an experienced business journalist and her skills are evident here.
Digging into the FDA's complex and conflicting world, the book provides an informative picture of FDA's bureaucratic, political, and scientific drivers. Ms. Hawthorne does an excellent job of laying out what the FDA is suppose to do, what is really does, and where and why it fails.
Medical Devices
The Guidebook for Medical Devices gives an perfect overview about the relevant FDA requierments for allmost all areas within the manufacture of medical devices. Topics like Process Validation, Calibration and in general Quality Systems are referenced with the specific Requierrments also in regard to ISO.
A must for every Quality Individual within the Medical Device Industry.
