Quality Control Training Manual : Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories book cover
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Quality Control Training Manual
Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories





ISBN 9781138077522
Published July 31, 2018 by CRC Press
484 Pages - 8 B/W Illustrations

 
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Book Description

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.

Table of Contents

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

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Author(s)

Biography

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

Support Material

Ancillaries