고려대학교 도서관

이전 결과로 돌아가기 검색화면

MARC

GMP training package library edition (1회 대출)

자료유형

단행본

개인저자

Farb, Daniel.

단체저자명

UniversityOfHealthCare.

서명 / 저자사항

GMP training package library edition / Daniel Farb ... [et al.].

발행사항

Los Angeles, CA : UniversityOfHealthCare , 2005.

형태사항

258 p. ; 23 cm. + 1 CD-ROM (4 3/4 in.).

총서사항

Interactive training library

ISBN

1594910960

요약

"Includes Agent GXP FDA part 11, Pharmaceutical computer validation introduction, and Pharmaceutical quality control lab. These three courses will give the learner an excellent introduction to the most important areas of modern pharmaceutical manufacturing"--p. 4 of manual cover.

일반주기

"The FDA regulations on part 11, electronic records and electronic signatures, for pharmaceutical, medical device, food, and cosmetics manufacturing and GMP (good manufacturing practices) training, and for clinical trials and GCP (good clinical practices), introduction to meet FDA regulations in the use of computers in pharmaceutical, medical device, food, and cosmetics manufacturing, with emphasis on computer system validation and part 11, covering FDA regulations of laboratory results, SOPs (standard operating procedures), and OOS(out of standard) and OOT (out of trend) results"--Manual cover.

일반주제명

Pharmaceutical industry -- United States -- Quality control. Pharmaceutical industry -- United States -- Data processing. Electronic records -- Law and legislation -- United States.

000		01907namuu2200289 a 4500
001		000045316973
005		20061227085658
008		061219s2005 cau 000 0 eng d
010		▼a 2005921496
020		▼a 1594910960
040		▼a 211009 ▼c 211009 ▼d 211009
082	0 4	▼a 338.476151 ▼2 22
090		▼a 338.476151 ▼b G569
245	0 0	▼a GMP training package library edition / ▼c Daniel Farb ... [et al.].
260		▼a Los Angeles, CA : ▼b UniversityOfHealthCare , ▼c 2005.
300		▼a 258 p. ; ▼c 23 cm. + ▼e 1 CD-ROM (4 3/4 in.).
440	0	▼a Interactive training library
500		▼a "The FDA regulations on part 11, electronic records and electronic signatures, for pharmaceutical, medical device, food, and cosmetics manufacturing and GMP (good manufacturing practices) training, and for clinical trials and GCP (good clinical practices), introduction to meet FDA regulations in the use of computers in pharmaceutical, medical device, food, and cosmetics manufacturing, with emphasis on computer system validation and part 11, covering FDA regulations of laboratory results, SOPs (standard operating procedures), and OOS(out of standard) and OOT (out of trend) results"--Manual cover.
520		▼a "Includes Agent GXP FDA part 11, Pharmaceutical computer validation introduction, and Pharmaceutical quality control lab. These three courses will give the learner an excellent introduction to the most important areas of modern pharmaceutical manufacturing"--p. 4 of manual cover.
650	0	▼a Pharmaceutical industry ▼z United States ▼x Quality control.
650	0	▼a Pharmaceutical industry ▼z United States ▼x Data processing.
650	0	▼a Electronic records ▼x Law and legislation ▼z United States.
700	1	▼a Farb, Daniel.
710	2	▼a UniversityOfHealthCare.
710	1	▼a United States. ▼b Food and Drug Administration.
945		▼a KINS

소장정보

과학도서관

No.	소장처	청구기호	등록번호	도서상태	반납예정일	예약	서비스
No. 1	소장처 과학도서관/Sci-Info(2층서고)/	청구기호 338.476151 G569	등록번호 121136288	도서상태 대출가능	반납예정일	예약	서비스 B M

GMP training package library edition (1회 대출)

소장정보

청구기호 브라우징

관련분야 인기자료

관련분야 신착자료