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작성자해병전우회 조회 12회 작성일 2021-05-14 20:31:42 댓글 0


에이치엘비제약 KGMP와 cGMP는 무엇이 다를까?

시청해주셔서 감사합니다.

빅토리채널은 절대로 종목추천을 하지 않으며 투자에 대한 책임은 본인의 판단에 달려 있음을 알려드립니다.

국내 의료기기 GMP 적합 인정 절차 (Korea Good Manufacturing Practice)

- ICMC (해외인증경영센터)는 해외글로벌 규격인증 및 국내,외 (RA:Regulatory Affairs) 인증전문기관.
- 주요품목는 바이오분야, 의료기기, 체외진단시약, 화장품, OTC, 식품, 안전보건,친환경제품분야등 국제규격및 제품인,허가를 기술지원...

1. 해외제품 인증분야.
-주요국가는 한국 MFDS (의료기기수입인허가 및 제조인허가, 의료기기GMP인증)
-유럽 CE (MDR/IVDR )
-미국 FDA (의료기기/체외진단시약/화장품VCRP, OTC)
-중국 NMPA (화장품/의료기기)
-일본 PMDA (의료기기,Cosmetics)

2. 국제시스템 인증분야.
- 국제시스템인증 및 ISO 심사원 과정(PECB -ISO Auditor Training)
- 인증심사규격: ISO 9001. ISO 14001. ISO 13485. ISO 22000. FSSC 22000. HACCP. ISO 22716. ISO 15378. ISO 45001. OHSAS 18001인증 기술지원업무등

3. 글로벌 수입 대행 및 무역업 (3rd Part Holder)
-한국 의료기기 수입대행 / /
T: 02-851-3111

GMP 101 - Intro to Good Manufacturing Practice [WEBINAR]

The quality of starting materials dramatically influences the properties of the final cellular product. Therefore the ultimate success of your cell product depends on the quality of the raw materials used. For the development of cell-based and gene therapy products regulatory authorities may require the use of strict procedures according to GMP regulations

Join Nicolas Danzenbächer and his webinar on Good Manufacturing Practice (GMP) and learn more about GMP guidelines in different countries and comparable regulations.

MACS Academy:

Miltenyi Biotec is a global provider of products and services that advance biomedical research and cellular therapy. Our innovative tools support research at every level, from basic research to translational research to clinical application. This integrated portfolio enables scientists and clinicians to obtain, analyze, and utilize the cell. Our technologies cover techniques of sample preparation, cell isolation, cell sorting, flow cytometry, cell culture, molecular analysis, and preclinical imaging. Our more than 25 years of expertise spans research areas including immunology, stem cell biology, neuroscience, and cancer, and clinical research areas like hematology, graft engineering, and apheresis. In our commitment to the scientific community, we also offer comprehensive scientific support, consultation, and expert training. Today, Miltenyi Biotec has more than 2,000 employees in 25 countries – all dedicated to helping researchers and clinicians around the world make a greater impact on science and health.




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