FDA警告信:避免和建议

Quality Assurance Journal Pub Date : 2011-07-01 DOI:10.1002/QAJ.488

T. Winchell

{"title":"FDA警告信:避免和建议","authors":"T. Winchell","doi":"10.1002/QAJ.488","DOIUrl":null,"url":null,"abstract":"Summary \n \n \nThis article provides an advisory approach regarding how to avoid an FDA Warning Letter following the receipt of a significant Form FDA 483. The focus is on the 483 response as it applies to GCP but can be applied to the response to the Warning Letter itself as well as a wider scope of GXP (GMP, GLP, GCP) inspection and audit responses. Copyright © 2011 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"52 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2011-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"FDA Warning Letter: Avoidance and Advice\",\"authors\":\"T. Winchell\",\"doi\":\"10.1002/QAJ.488\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Summary \\n \\n \\nThis article provides an advisory approach regarding how to avoid an FDA Warning Letter following the receipt of a significant Form FDA 483. The focus is on the 483 response as it applies to GCP but can be applied to the response to the Warning Letter itself as well as a wider scope of GXP (GMP, GLP, GCP) inspection and audit responses. Copyright © 2011 John Wiley & Sons, Ltd.\",\"PeriodicalId\":147931,\"journal\":{\"name\":\"Quality Assurance Journal\",\"volume\":\"52 1\",\"pages\":\"0\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2011-07-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Quality Assurance Journal\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1002/QAJ.488\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Quality Assurance Journal","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1002/QAJ.488","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}

引用次数: 1

摘要

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

FDA Warning Letter: Avoidance and Advice

Summary This article provides an advisory approach regarding how to avoid an FDA Warning Letter following the receipt of a significant Form FDA 483. The focus is on the 483 response as it applies to GCP but can be applied to the response to the Warning Letter itself as well as a wider scope of GXP (GMP, GLP, GCP) inspection and audit responses. Copyright © 2011 John Wiley & Sons, Ltd.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Quality Assurance Journal

自引率

0.00%

发文量