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GMP Case Study: Lessons from FDA 483s & Warning Letters

 

 


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gmpeye´Â °³ÀÎ Á¤º¸¸¦ ¼öÁýÇÏÁö ¾Ê½À´Ï´Ù. °£´ÜÇÏ°Ô "´º½º·¹ÅÍ ½Åû"À̶ó°í Á¦¸ñÀ» ½á¼­ À̸ÞÀÏÀ» Áֽøé e-newsletter¸¦ º¸³»µå¸³´Ï´Ù. e-newsletter ¼ö½ÅÀ» ¿øÇÏÁö ¾ÊÀ¸¸é "´º½º·¹ÅÍ °ÅºÎ"¶ó°í Á¦¸ñÀ» ½á¼­ À̸ÞÀÏÀ» ÁÖ½Ã¸é ¹ß¼Û ¸®½ºÆ®¿¡¼­ »èÁ¦ÇÏ°Ú½À´Ï´Ù.

 

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¹Ì±¹ FDAÀÇ GMP ½Ç»ç »ç·Ê ¹®¼­´Â GMP ¾÷¹«¸¦ °³¼±ÇÏ°í ±ÔÁ¦ ±â°üÀÇ GMP ½Ç»ç¸¦ ´ëºñÇϴµ¥ µµ¿òÀÌ µÇ¸®¶ó »ý°¢ÇÕ´Ï´Ù. GMP Case Study ¹®¼­¸¦ Àμ⠰¡´ÉÇÑ PDF ÆÄÀÏ·Î ÆǸÅÇÏ°í ÀÖÀ¸´Ï, ±¸ÀÔÀ» ¿øÇϽô ºÐÀº ¾Æ·¡·Î ¿¬¶ô Áֽñ⠹ٶø´Ï´Ù.

 

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GMP Case Study: Lessons from FDA 483s & Warning Letters (~ 2015³â)

 

GMP Case Study: Lessons from FDA 483s & Warning Letters - Volume 1 (156ÆäÀÌÁö)

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GMP Case Study: Lessons from FDA 483s & Warning Letters - Volume 2 (163ÆäÀÌÁö)

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GMP Case Study: Lessons from FDA 483s & Warning Letters - Volume 3 (155ÆäÀÌÁö)

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GMP Case Study: Lessons from FDA 483s & Warning Letters - Volume 4 (165ÆäÀÌÁö)

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GMP Case Study: Lessons from FDA 483s & Warning Letters - Volume 5 (154ÆäÀÌÁö)

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GMP Case Study: Lessons from FDA 483s & Warning Letters - Volume 6 (151ÆäÀÌÁö)

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GMP Case Study: Lessons from FDA 483s & Warning Letters - Volume 7 (216ÆäÀÌÁö)

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GMP Case Study: Lessons from US FDA Warning Letters 2016 (251ÆäÀÌÁö)

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GMP Case Study: Lessons from US FDA Warning Letters 2017 (378ÆäÀÌÁö)

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GMP Case Study: Lessons from US FDA Warning Letters 2018 (440ÆäÀÌÁö)

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GMP Case Study: Lessons from US FDA Warning Letters 2019 (429ÆäÀÌÁö)

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GMP Case Study: Lessons from US FDA Warning Letters 2020 (418ÆäÀÌÁö)

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GMP Case Study: Lessons from US FDA Warning Letters 2021 (451ÆäÀÌÁö)

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GMP Case Study: Lessons from US FDA Warning Letters 2022 (238ÆäÀÌÁö)

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GMP Case Study: Lessons from US FDA Warning Letters 2023 (391ÆäÀÌÁö) New

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GMP Case Study: Lessons from US FDA 483s 2020/2021 (221ÆäÀÌÁö)

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GMP Case Study: Lessons from US FDA 483s 2022³â »ó¹Ý±â (110ÆäÀÌÁö)

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GMP Case Study: Lessons from US FDA 483s 2022³â ÇϹݱâ (197ÆäÀÌÁö)

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GMP Case Study: Lessons from US FDA 483s 2023³â »ó¹Ý±â (195ÆäÀÌÁö)

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GMP Case Study: Lessons from US FDA 483s 2023³â ÇϹݱâ (176ÆäÀÌÁö) New

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GMP Case Study: Lessons from US FDA 483s 2024³â »ó¹Ý±â (228ÆäÀÌÁö) New

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