000			03426nam a2200421Ia 4500
001			231120
003			0000000000
005			20211104055259.0
008			110216s2011 flu b 001 0 eng
010			_a2011007229
020			_a9781439849941
050			_aRS 192 _b.H124 2011
100			_aHaider, Syed Imtiaz. _9117150
245		0	_aQuality control training manual : _bcomprehensive training guide for API, finished pharmaceutical and biotechnologies laboratories / _cSyed Imtiaz Haider, Erfan Syed Asif.
260			_aBoca Raton, FL : _bCRC Press, _cc2011.
300			_axxcii, 456 p. _c24 cm. +
504			_aIncludes bibliographical references and index.
520			_aWritten 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			_aBiotechnology
650			_aBiotechnology _9117151
650			_aDrug Industry _9117152
650			_aDrug Industry _9117152
650			_aLaboratories _919759
650			_aLaboratories _919759
650			_aMedical laboratories _9117153
650			_aMedical laboratories _9117153
650			_aPharmaceutical Preparations _9102246
650			_aPharmaceutical Preparations _9102246
650			_aPharmaceutical technology _9117154
650			_aPharmaceutical technology _9117154
650			_aQuality Control
650			_aQuality Control _9117155
650			_aTechnology, Pharmaceutical _9117156
650			_aTechnology, Pharmaceutical _9117156
700			_aAsif, Erfan Syed. _9117157
942			_cREF
999			_c82538 _d82538