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Table of Contents
第1章 指摘を受けないPre−Approval Inspection［承認前査察］対策
はじめに/ 3
1． FDA査察とは/ 3
2． FDA査察に対する心構え/ 4
2．1 FDAから派遣されてくるのは査察官(？)/ 4
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- Material Type
- 図書
- ISBN
- 4-906317-98-7
- Title Transcription
- シテキ オ ウケナイ タメノ FDA EMEA ニ オケル GMP システム ササツ ト FDA483 Warning Letters タイサク
- Publication, Distribution, etc.
- Publication Date
- 2003.3
- Publication Date (W3CDTF)
- 2003
- Extent
- 222p
- Size
- 27cm
- Place of Publication (Country Code)
- JP