Quality Control Training Manual - Syed Imtiaz Haider, Syed Erfan Asif

Quality Control Training Manual

Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories
Buch | Hardcover
484 Seiten
2011
Crc Press Inc (Verlag)
978-1-4398-4994-1 (ISBN)
205,75 inkl. MwSt
A valuable tool for chemists and analysts working in Quality Control laboratories, this book provides technical solutions that fulfill training requirements and build skilled manpower. The text is written for practitioners in quality control laboratories, product development laboratories, and stability laboratories in pharmaceutical and bio-phar
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 downloadable resources 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 downloadable resources 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 downloadable resources supply valuable tools for developing training matrices to achieve FDA, Health Canada, EMEA, MHRA UK, WHO, and GLP compliance.

Syed Imtiaz Haider, Ph.D. is Quality Affairs Director at Gulf Pharmaceutical Industries (GPI) in the United Arab Emirates.

Preface. Analytical Methods, Techniques and Quality Measures for General Pharmaceutical Products. Analytical Methods and Techniques for Biological Products. Laboratory Training Manual. Assessment of Training. Training Assessment with Quiz and Answers. Training Log. Analytical Method Validation Master Plan. Analytical Methods Validation Protocol. SOP for Annual Re-Qualification of HPLC Units. SOP for Annual Re-Qualification of GC Units. ABC Pharmaceutical Company. Regulations. Index.

Erscheint lt. Verlag 28.3.2011
Zusatzinfo 25 Tables, black and white; 8 Illustrations, black and white
Verlagsort Bosa Roca
Sprache englisch
Maße 152 x 229 mm
Gewicht 793 g
Themenwelt Medizin / Pharmazie Medizinische Fachgebiete Laboratoriumsmedizin
Medizin / Pharmazie Medizinische Fachgebiete Pharmakologie / Pharmakotherapie
Naturwissenschaften Biologie
Technik Umwelttechnik / Biotechnologie
ISBN-10 1-4398-4994-3 / 1439849943
ISBN-13 978-1-4398-4994-1 / 9781439849941
Zustand Neuware
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