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Quality Control Training Manual - Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories (Paperback)
Loot Price: R1,777
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Quality Control Training Manual - Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories (Paperback)
Expected to ship within 12 - 17 working days
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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.
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