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GMP training package library edition (Loan 1 times)

Material type

단행본

Personal Author

Farb, Daniel.

Corporate Author

UniversityOfHealthCare.

Title Statement

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

Publication, Distribution, etc

Los Angeles, CA : UniversityOfHealthCare , 2005.

Physical Medium

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

Series Statement

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.

General Note

"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.

Subject Added Entry-Topical Term

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

Holdings Information

Science & Engineering Library

No.	Location	Call Number	Accession No.	Availability	Due Date	Make a Reservation	Service
No. 1	Location Science & Engineering Library/Sci-Info(Stacks2)/	Call Number 338.476151 G569	Accession No. 121136288	Availability Available	Due Date	Make a Reservation	Service B M

GMP training package library edition (Loan 1 times)

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