MARC details
000 -LEADER |
fixed length control field |
03426nam a2200421Ia 4500 |
001 - CONTROL NUMBER |
control field |
231120 |
003 - CONTROL NUMBER IDENTIFIER |
control field |
0000000000 |
005 - DATE AND TIME OF LATEST TRANSACTION |
control field |
20211104055259.0 |
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
fixed length control field |
110216s2011 flu b 001 0 eng |
010 ## - LIBRARY OF CONGRESS CONTROL NUMBER |
LC control number |
2011007229 |
020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
International Standard Book Number |
9781439849941 |
050 ## - LIBRARY OF CONGRESS CALL NUMBER |
Classification number |
RS 192 |
Item number |
.H124 2011 |
100 ## - MAIN ENTRY--PERSONAL NAME |
Personal name |
Haider, Syed Imtiaz. |
9 (RLIN) |
117150 |
245 #0 - TITLE STATEMENT |
Title |
Quality control training manual : |
Remainder of title |
comprehensive training guide for API, finished pharmaceutical and biotechnologies laboratories / |
Statement of responsibility, etc. |
Syed Imtiaz Haider, Erfan Syed Asif. |
260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
Place of publication, distribution, etc. |
Boca Raton, FL : |
Name of publisher, distributor, etc. |
CRC Press, |
Date of publication, distribution, etc. |
c2011. |
300 ## - PHYSICAL DESCRIPTION |
Extent |
xxcii, 456 p. |
Dimensions |
24 cm. + |
504 ## - BIBLIOGRAPHY, ETC. NOTE |
Bibliography, etc |
Includes bibliographical references and index. |
520 ## - SUMMARY, ETC. |
Summary, etc. |
Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences to produce commercially viable biotech products and services in terms of quality, safety, and efficacy. This book and its accompanying CD-ROM comprise detailed text, summaries, test papers, and answers to test papers, providing an administrative solution for management. Provides the FDA, Health Canada, WHO, and EMEA guidelines directly applicable to pharmaceutical laboratory-related issues. Offers generic formats and styles that can be customized to any organization and help management build quality into routine operations to comply with regulatory requirements. Contains ready-to-use training courses that supply a good source of training material for experienced and inexperienced practitioners in the biotechnology/biopharmaceutical industries. Includes a CD with downloadable training courses that can be adopted and directly customized to a particular organization. Supplies ready-to-use test papers that allow end users to record all raw data up to the issuance of the attached certificate. The biotechnology/bioscience industries are regulated worldwide to be in compliance with cGMP and GLP principles, with particular focus on safety issues. Each company must create a definite training matrix of its employees. The training procedures in this book enable end users to understand the principles and elements of manufacturing techniques and provide documentation language ranging from the generic to the specific. The training courses on the CD supply valuable tools for developing training matrices to achieve FDA, Health Canada, EMEA, MHRA UK, WHO, and GLP compliance |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name as entry element |
Biotechnology |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name as entry element |
Biotechnology |
9 (RLIN) |
117151 |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name as entry element |
Drug Industry |
9 (RLIN) |
117152 |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name as entry element |
Drug Industry |
9 (RLIN) |
117152 |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name as entry element |
Laboratories |
9 (RLIN) |
19759 |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name as entry element |
Laboratories |
9 (RLIN) |
19759 |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name as entry element |
Medical laboratories |
9 (RLIN) |
117153 |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name as entry element |
Medical laboratories |
9 (RLIN) |
117153 |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name as entry element |
Pharmaceutical Preparations |
9 (RLIN) |
102246 |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name as entry element |
Pharmaceutical Preparations |
9 (RLIN) |
102246 |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name as entry element |
Pharmaceutical technology |
9 (RLIN) |
117154 |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name as entry element |
Pharmaceutical technology |
9 (RLIN) |
117154 |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name as entry element |
Quality Control |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name as entry element |
Quality Control |
9 (RLIN) |
117155 |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name as entry element |
Technology, Pharmaceutical |
9 (RLIN) |
117156 |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name as entry element |
Technology, Pharmaceutical |
9 (RLIN) |
117156 |
700 ## - ADDED ENTRY--PERSONAL NAME |
Personal name |
Asif, Erfan Syed. |
9 (RLIN) |
117157 |
942 ## - ADDED ENTRY ELEMENTS (KOHA) |
Koha item type |
Reference |