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This Second Edition is an essential guide to preparing for FDA pre-approval inspectionsa "taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based approach to inspections, risk-based inspections, quality by design, process analytical technology, design space, etc. The goal of this book is to help organizations gain rapid regulatory approval.
Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition:
- chronicles the major shifts in inspection activity as evidenced by a systems-based approach to inspections
- demonstrates what each area of pharmaceutical development, from research and development to training, is expected to provide to inspectors
- focuses on traditional development and submission activities, but also discusses cases where the transfer is from a domestic site to an international facility
A peaceful demonstration in the normally quiet town of Eastvale ended with fifty arrests -- and the brutal stabbing death of a young constable. But Chief Inspector Alan Banks fears there is worse violence in the offing. For CID Superintendent Richard "Dirty Dick" Burgess has arrived from London to take charge of the investigation, fueled by professional outrage and volatile, long-simmering hatreds.
Almost immediately, Burgess descends with vengeful fury upon the members of a sixties-style commune -- while Banks sifts through the rich Yorkshire soil around him, turning over the earthy, unsettling secrets of seemingly placid local lives. Crossing "Dirty Dick" could cost the Chief Inspector his career. But the killing of a flawed Eastvale policeman is not the only murder that needs to be solved here. And if Banks doesn't unmask the true assassin, his superior's misguided obsession might well result in further bloodshed.
About the Author
Peter Robinson's award-winning novels have been named a Best Book of the Year by Publishers Weekly, a Notable Book by the New York Times, and a Page-Turner of the Week by People magazine. Robinson was born and brought up in Yorkshire, England, and now divides his time between North America and Richmond, Yorkshire.
Smart Move Inspections
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