A valuable tool that makes the adoption and incorporation of the requirements of the ISO 14001:2004 standards relatively painless, Environmental Management System ISO 14001: 2004: Handbook of Transition with CD-ROM provides the practical know-how required to make a successful documented Environmental Management System (EMS) based on the ISO 14001:2004 series of standards, which has acquired global acceptance in overcoming international trade barriers. It supplies step-by-step guidance on how to develop and implement an EMS that, with little effort, can be instantly applied to any process-related industry or organization interested in environmental compliance.

A complete, single-source reference, written in simple and precise language, the book puts the answers to complex and thorny issues at your fingertip. It includes samples of policy statements, objectives, targets, and programs that can be amended or adopted without re-inventing the wheel and losing time. The CD-ROM includes customizable Standard Operating Procedures (SOPs) that can be downloaded, edited, printed and easily tailored to incorporate changes and add organizational requirements. The SOPs exclusively refer to the documents specially required for compliance; however specific formats are included to ensure that the soft copy can be easily used worldwide in a diverse range of industries and organizations.

The book helps you minimize documentation and avoid the nightmare of management representatives at the time of certification. An effective time saver when you are in the process of writing and organizing documentation for the certification and further improvement purposes, this book and CD-ROM package helps you easily translate the revised ISO 14001:1996 and ISO 14001:2004 standard requirements into immediate action.

Don't reinvent the wheel when applying for your ISO 9001 registration or updating to the new 2000 standards. ISO 9001:2000 Document Development Compliance Manual: A Complete Guide and CD-ROM shows you how to develop and implement a documented quality management system based on ISO 9000 series standards. It supplies ready to use ISO 9001:2000 Template Quality Manuals and applicable Standard Operating Procedures with year 2000 revisions for documentation management in text and on CD ROM. You will understand how to: oBuild quality into your products and servicesoAchieve ISO 9001 certification with time, money, and resources optimization oSupply products that are totally fit for use oSatisfy user/customer expectations oEdge out the competitors oAchieve a defined level of quality oPrevent defects and provide value oYield profits from your invested resources

All manufacturing companies face the daunting task of designing an employee training matrix that meets the gamut of national and international regulatory standards. Answering the call for a one-stop training resource that focuses exclusively on this multi-faceted, high-tech industry, Biotechnology: A Comprehensive Training Guide for the Biotechnology Industry provides ready-to-implement training templates that save time and expense without cutting corners on critical elements.

Attached CD-ROM: Why Reinvent the Wheel?

This complete, single-source reference contains 28 complete biotechnology courses and a customizable CD-ROM with hands-on training tools. The book also provides time-saving information on how to orient employees involved in writing and executing batch manufacturing and in-process control documents.

Key Benefits:

• Contains adaptable training text, test summaries and papers, test answers, and certificates of completion
• Streamlines the training process, maximizing efficiency
• Boosts the marketing edge over competitors

During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them provides a single database with convenient, ready-to-use training tools. Until now. Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries elucidates how to train the man power involved in development, manufacturing, auditing, and validation of bio pharmaceuticals on a pilot scale, leading to scale-up production.

With over 20 easy-to-use template protocols for cleaning validation of extensively used equipments, this book provides technical solutions to assist in fulfilling the training needs of finished pharmaceutical manufacturers. Drawing on the authors’ more than two decades of experience in the pharmaceutical and biotech industries, the text offers hands-on training based on current approaches and techniques. The book does not merely provide guidelines or thought processes, rather it gives ready-to-use formulas to develop Master Plan, SOPs, and validation protocols. It includes cleaning procedures for the most commonly used equipment in various manufacturing areas and their sampling points, using a pharmaceutical manufacturing site with both sterile and non-sterile operations as the case facility. It also provides the training guidelines on a CD-ROM to enable users to amend or adopt them as necessary.

Grounded in practicality, the book’s applicability and accessibility set it apart. It can be used as a guide for implementing a cleaning validation program on site without the help of external consultants, making it a resource that will not be found collecting dust on a shelf, but rather, referred to again and again.