| FDA Establishment Inspections: Pharmaceutical, Biotechnology, Medical Device and Food Manufacturing Concise Reference Contributor(s): Allport-Settle, Mindy J. (Author) |
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ISBN: 098214766X ISBN-13: 9780982147665 Publisher: Pharmalogika OUR PRICE: $31.34 Product Type: Paperback Published: July 2010 |
| Additional Information |
| BISAC Categories: - Technology & Engineering | Manufacturing |
| Physical Information: 0.74" H x 5.98" W x 9.02" (1.05 lbs) 358 pages |
| Descriptions, Reviews, Etc. |
| Publisher Description: Establishment Inspections, Chapter 5 of the FDA's Investigations Operations Manual, details every step FDA inspectors are required to follow when conducting a facility inspection. This text is a comprehensive reference for regulatory inspections and is useful as an introduction to the practical components of the FDA-regulated industries or as a refresher. While the specific regulations and requirements may differ widely between pharmaceutical, biotechnology, medical device, and food manufacturers, the inspection processes and procedures do not. |