ISO 14001 Environmental Systems Handbook

ISO 14001 Environmental Systems Handbook
By Ken Whitelaw

Description:

ISO 14001 Environmental Systems Handbook Second Edition outlines the scope and purpose of the standard, making it accessible to all.

The author begins by explaining the concepts of the standard, which sets the tone for a practical guide to implementation of an ISO 14000-compliant environmental management system, which also covers the consultant's and auditor's perspective.

The case studies from industries that have actually undergone the process have been updated to include information on their progress toward environmental objectives in the 18-24 months following implementation. A new case study from a service organisation ( a car lease company) will be added. Finally there is input from training organisations and certification and accreditation bodies to assist with trouble-shooting and assessment. Additional information is also included on international legislative issues. Comparisons with ISO 9000 will also be fully updated to reflect revisions to this standard.


The book will offer the reader a range of options for implementation, and guidance on which is the best option to suit the particular organisation's culture.

* Fully updated to meet the new 2004 amendments to ISO 14001
* New case studies to show how ISO14001 is being implemented and is working for key organisations
* Proven track record of making understanding and implementing ISO14001 accessible

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Environmental management system ISO 14001

Environmental management system ISO 14001

Description:

Environmental management system ISO 14001 -35 searching questions and contrasting pairs of examples The book is intended as a guide and work book for people taking part in a self evaluation process. The book describes the contents of the ISO 14001 standard using 35 questions and contrasting pairs of examples. The book can be used to help you understand the standard without any training. The book can be used to identify areas for development by comparing your own practices with those stipulated in the standard. The examples in the book help the self evaluation participants to understand what each of the questions means. For every question, an evaluation is made of its importance, as well as its current and target performance capability, on a scale of 1 - 5. The self assessment question form can be opened in the screen and filled out while reading the book. After filling in all the questions the result can be printed out. You do not need to be familiar with the ISO 14001 standard in order to answer the questions, just give your evaluation on the basis of your own imagination. The book’s job is to help you develop your imagination. The book, questions and self evaluation process can be adapted as a development tool and training material for the organisation even if the organisation does not adopt the ISO 14001 standard.

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Microbiological Contamination Control in Pharmaceutical Clean Rooms

Microbiological Contamination Control in Pharmaceutical Clean Rooms
By Nigel Halls

Description:

This book neatly clarifies some of the perceived problems surrounding contamination control in pharmaceutical industry clean rooms. It helps manufacturers satisfy both domestic and international regulations and prevent their companies from suffering the consequences of non-compliance. It includes up-to-date information on microbiological contamination in sterile manufacturing, microbiological media fills, microbiological environmental monitoring, control in aqueous-based, non-sterile pharmaceuticals, rapid testing methods, and clean room contamination control. This book is an important resource for the microbiologist working in pharmaceutical manufacturing.

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Validation of Pharmaceutical Processes: Sterile Products

Validation of Pharmaceutical Processes: Sterile Products, Second Edition, Revised and
By Frederick J. Caleton, James P. Agalloco

Description:

Featuring contributions from 25 specialists, this book provides a single-source reference on the design of systems, qualification of equipment, calibration and certification. It covers explicit procedures for the validation of systems required in the preparation of aseptic and nonaseptic pharmaceutical products. Topics include installation qualification, operational qualification, and change control, F, D, and Z values, steam sterilization-in-place technology and validation, sterilization methods, protocols that allow procedures to be applied directly, obstacles that may be encountered at any stage of the validation program and suggested the solutions.

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Analytical Method Validation and Instrument Performance Verification

Analytical Method Validation and Instrument Performance Verification

Description:

Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.

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Analytical Method Development and Validation

Analytical Method Development and Validation
By Michael E. Swartz, Ira S. Krull

Description:

Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.

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