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Quality control training manualcompr...

Asif, Erfan Syed.

Quality control training manualcomprehensive training guide for API, finished pharmaceutical and biotechnologies laboratories /

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Quality control training manualSyed Imtiaz Haider, Erfan Asif Syed.
其他題名:	comprehensive training guide for API, finished pharmaceutical and biotechnologies laboratories /
作者:	Haider, Syed Imtiaz.
其他作者:	Asif, Erfan Syed.
出版者:	Boca Raton :CRC Press,2011.
面頁冊數:	1 online resource (xxix, 456 p.) :ill.
標題:	Medical laboratoriesStandards.
電子資源:	http://www.crcnetbase.com/isbn/978-1-4398-4994-1
ISBN:	9781439850169 (electronic bk.)

Quality control training manualcomprehensive training guide for API, finished pharmaceutical and biotechnologies laboratories /
Haider, Syed Imtiaz.

Quality control training manualcomprehensive training guide for API, finished pharmaceutical and biotechnologies laboratories /[electronic resource] :Syed Imtiaz Haider, Erfan Asif Syed. - Boca Raton :CRC Press,2011. - 1 online resource (xxix, 456 p.) :ill.

Includes bibliographical references and index.

Qct-01. Analytical methods, techniques and quality measures for general pharmaceutical products -- qct-02. Analytical methods, techniques and quality measures for biological products -- qct-03. Laboratory training manual -- qct-04. Assessment of training -- qct-05. Training assessment with quiz and answers -- qct-06. Training log -- qct-07. Analytical method validation master plan -- qct-08. Analytical methods validation protocol -- qct-09. SOP for annual re-qualification of HPLC units -- qct-10. SOP for annual re-qualification of GC units -- qct-11. ABC pharmaceutical company -- qct-12. Regulations.

"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"--Provided by publisher.

ISBN: 9781439850169 (electronic bk.)Subjects--Topical Terms:

649588
Medical laboratories
--Standards.Index Terms--Genre/Form:

214472
Electronic books.

LC Class. No.: RS192 / .H352 2011

Dewey Class. No.: 615.19 / H149

National Library of Medicine Call No.: QV 18.2

Quality control training manualcomprehensive training guide for API, finished pharmaceutical and biotechnologies laboratories /
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245 1 0 $a Quality control training manual $h [electronic resource] : $b comprehensive training guide for API, finished pharmaceutical and biotechnologies laboratories / $c Syed Imtiaz Haider, Erfan Asif Syed.
260 $a Boca Raton : $b CRC Press, $c 2011.
300 $a 1 online resource (xxix, 456 p.) : $b ill.
504 $a Includes bibliographical references and index.
505 0 $a Qct-01. Analytical methods, techniques and quality measures for general pharmaceutical products -- qct-02. Analytical methods, techniques and quality measures for biological products -- qct-03. Laboratory training manual -- qct-04. Assessment of training -- qct-05. Training assessment with quiz and answers -- qct-06. Training log -- qct-07. Analytical method validation master plan -- qct-08. Analytical methods validation protocol -- qct-09. SOP for annual re-qualification of HPLC units -- qct-10. SOP for annual re-qualification of GC units -- qct-11. ABC pharmaceutical company -- qct-12. Regulations.
520 $a "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"--Provided by publisher.
588 $a Description based on print version record.
650 0 $a Medical laboratories $x Standards. $3 649588
650 0 $a Pharmaceutical technology $x Standards. $3 520503
650 0 $a Medical laboratories $x Examinations, questions, etc. $3 649589
650 0 $a Pharmaceutical technology $x Examinations, questions, etc. $3 649590
650 1 2 $a Laboratories $x standards $v Examination Questions. $3 649591
650 1 2 $a Technology, Pharmaceutical $x standards $v Handbooks. $3 610889
650 2 2 $a Biotechnology $x standards $v Examination Questions. $3 649592
650 2 2 $a Drug Industry $x standards $v Handbooks. $3 610888
650 2 2 $a Pharmaceutical Preparations $x standards $v Laboratory Manuals. $3 446238
650 2 2 $a Quality Control $v Laboratory Manuals. $3 446240
655 4 $a Electronic books. $2 local. $3 214472
700 1 $a Asif, Erfan Syed. $3 649587
856 4 0 $u http://www.crcnetbase.com/isbn/978-1-4398-4994-1