ÀÇ·á±â±â ¹Ì±¹ FDA cGMP ½Ç¹«(24³â 1Â÷)
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¡á°ú Á¤ ¸í : ÀÇ·á±â±â ¹Ì±¹FDA cGMP ½Ç¹«(24³â 1Â÷)
¡á±³À°±â°£ : 2024. 05. 21(È). ~ 2024. 05. 22(¼ö)
¡á±³À°½Ã°£ : 09:30~17:30 (1ÀÏ 7½Ã°£ / ÃÑ 14½Ã°£)
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¡á±³À°Àοø : 30¸í
¡á±³À°Æ¯Àü : ½Ä±Ç, ±³Àç ¹«»óÁ¦°ø ¹× ¼ö·áÁõ ¹ß±Þ
* Á¢¼öÀÏ : 2024.04.25 (¸ñ) 10:00~
* ¼ö·á°¡ °¡´ÉÇϽŠºÐ¸¸ ½Åû°¡´ÉÇÕ´Ï´Ù.
1ÀÏÂ÷ (09:30 ~ 10:30)
- ¹Ì±¹ cGMP inspection ÇÁ·Î¼¼½º(1½Ã°£)
- ¹Ì±¹ cGMP inspection ÇÁ·Î¼¼½º(21 CFR Part820 -Management control)(2½Ã°£)
- ¹Ì±¹ cGMP inspection ÇÁ·Î¼¼½º(21 CFR Part820 -Corrective and Preventive Actions(2½Ã°£)
- ¹Ì±¹ cGMP inspection ÇÁ·Î¼¼½º(21 CFR Part820 -Corrective and Process Controls(2½Ã°£)
2ÀÏÂ÷ (09:30 ~ 10:30)
- ¹Ì±¹ cGMP inspection ÇÁ·Î¼¼½º(21 CFR Part820 -Material Controls)(1½Ã°£)
- ¹Ì±¹ cGMP inspection ÇÁ·Î¼¼½º(21 CFR Part820 -Documents/REcords/Change Control)(1½Ã°£)
- ¹Ì±¹ eMDR µî·Ï ÇÁ·Î¼¼½º(1½Ã°£)
- Á¦Ç°À̷±â·Ï(DHR)ÀÛ¼º »ç·Ê¿¬±¸(1½Ã°£)
- ¹Ì±¹ cGMP ÁöÀû»çÇ× »ç·Ê¿¬±¸(1½Ã°£)
- 483 Observation ÈļÓÁ¶Ä¡ »ç·Ê¿¬±¸(2½Ã°£)
* Áᫎ : 12:30~13:30