Violations Of 21 CFR Part 312 - Investigational New Drug Application: Warning Le

Description: Violations Of 21 CFR Part 312 - Investigational New Drug Application by C. Chang Estimated delivery 3-12 business days Format Paperback Condition Brand New Description Inspection teams often know that a deficiency at one company will often be found at others, so they tend to look for what teams have found in previous inspections. A numerical analysis of past inspections results in the discovery of inspection trends for future inspections. This analysis contains a collection of violations listed in the Warning Letters (WLs) issued by U.S. Food and Drug Administration (FDA) that are available to the public on FDA website, , as of May 23, 2015. Specifically, the violations included in this analysis are extracted from Warning Letters issued since January 2005. The violations collected here are specifically for failures to meet the requirements described in U.S. Code of Federal Regulations (CFR) Title 21 Food and Drugs, Part 312 Investigational New Drug Application. As of May 23, 2015, there were 121 warning letters issued describing violations of Code of Federal Regulations Title 21 - Food and Drugs Part 312 Investigational New Drug Application. Within these warning letters, 382 violations are listed in this book. The analysis also includes summary of FDA Inspectional Observation issued on Form 483. Author Biography C. Y. CHANG, PhD, is a National Chair Professor at the National Chiao Tung University in Hsinchu, Taiwan. S. M. SZE, PhD, is UMC Chair Professor at the National Chiao Tung University. Details ISBN 1514626632 ISBN-13 9781514626634 Title Violations Of 21 CFR Part 312 - Investigational New Drug Application Author C. Chang Format Paperback Year 2015 Pages 426 Publisher Createspace Independent Publishing Platform GE_Item_ID:95973022; About Us Grand Eagle Retail is the ideal place for all your shopping needs! With fast shipping, low prices, friendly service and over 1,000,000 in stock items - you're bound to find what you want, at a price you'll love! Shipping & Delivery Times Shipping is FREE to any address in USA. Please view eBay estimated delivery times at the top of the listing. Deliveries are made by either USPS or Courier. We are unable to deliver faster than stated. International deliveries will take 1-6 weeks. NOTE: We are unable to offer combined shipping for multiple items purchased. This is because our items are shipped from different locations. Returns If you wish to return an item, please consult our Returns Policy as below: Please contact Customer Services and request "Return Authorisation" before you send your item back to us. Unauthorised returns will not be accepted. Returns must be postmarked within 4 business days of authorisation and must be in resellable condition. Returns are shipped at the customer's risk. We cannot take responsibility for items which are lost or damaged in transit. For purchases where a shipping charge was paid, there will be no refund of the original shipping charge. Additional Questions If you have any questions please feel free to Contact Us. Categories Baby Books Electronics Fashion Games Health & Beauty Home, Garden & Pets Movies Music Sports & Outdoors Toys

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