<p>This book is written for the industry that develops, manufactures, and markets medical products for human and veterinary use. This industry is regulated by the FDA. The documents and the document management systems presented in this text, however, can be applied to any regulated industry, such as the EPA, USDA, or OSHA, or to any industry that develops or manufactures products for human use.</p>

Documentation Practices: A Complete Guide to Document Development and Management of GMP and ISO 9000 Compliant Industries

Business & Money

DeSain, Carol

Management & Leadership

Advanstar Communications

Documentation Basics, second edition, includes everything you need to know about establishing a company-wide documentation system that meets GMP and QSR requirements. Documentation Basics, second edition, continues to provide - like the first edition - a minimum set of standards to consider when designing document identification numbering systems or writing standard operating procedures, specifications, quality manuals, logbooks, etc. Newly added features to the 2nd Edition are basic documentation practices for specific functional areas of operations such as Maintenance, Material Handling, Validation, Quality Control, Quality Assurance, and Production. In medical manufacturing environments, a sound, sensible and simple documentation system is the foundation of GMP. Using sample documents and simple, step-by-step instructions, this book outlines the major components of a documentation system, demonstrates how they interact and provides examples of their design, format and content. This comprehensive, hands-on guide will enable you to design an effective documentation system that ensures quality standards are met, minimizes errors, reduces downtime and serves as a training tool for line workers and administrators.

Documentation Basics That Support Good Manufacturing Practices and Quality System Regulations

Advanstar Marketing Services

Drug, device and diagnostic manufacturing: The ultimate resource handbook

Interpharm Press

This book is used by hundreds of drug based companies world wide. 
In this first edition you can expect practical information in regards to all aspects of research.

Drug, Device and Diagnostic Manufacturing: The Ultimate Resource Handbook

Medical Books

Interpharm Pr

Implementing international drug, device, and diagnostic GMP's: A practical guide

Interpharm Press, Inc

Documentation Basics that Support Good Manufacturing Practices is a clear, concise guide to establishing a documentation system for validation of equipment, utilities, analytical methods and processes in a medical manufacturing enviromment . Author and independent consultant Carol DeSain leads the reader through the steps necessary to establish a documentation system meeting GMP requirements -- turning what is often an overwhelming task into a straightforward procedure. Using sample documents and simple, step-by-step instructions, DeSain demonstrates how to track any method or process, from master batch production to equipment validation, maintenance and repair. She shows how to set in place a standardized, company-wide documentaiton system that will serve to validate any manufacturing process; how to create Standard Operating Procedures that are truly informative; and how to write and design documents that communicate effectively. Professionals outside the medical manufacturing industry will also find that the validation system presented in Documentation Basics is easily adapted to any business or industrial environment.

Documentation Basics That Support Good Manufacturing Practices

Aster Pub. Corp

Documentation Basics that Support Good Manufacturing Practices is a clear, concise guide to establishing a documentation system for validation of equipment, utilities, analytical methods and processes in a medical manufacturing enviromment .  Author and independent consultant Carol DeSain leads the reader through the steps necessary to establish a documentation system meeting GMP requirements -- turning what is often an overwhelming task into a straightforward procedure.  Using sample documents and simple, step-by-step instructions, DeSain demonstrates how to track any method or process, from master batch production to equipment validation, maintenance and repair.  She shows how to set in place a standardized, company-wide documentaiton system that will serve to validate any manufacturing process; how to create Standard Operating Procedures that are truly informative; and how to write and design documents that communicate effectively.  Professionals outside the medical manufacturing industry will also find that the validation system presented in Documentation Basics is easily adapted to any business or industrial environment.

Documentation Basics: That Support Good Manufacturing Practices

<p>This is the story about the relationship between Betsy Powell and Saganaga Lake. For nearly 70 years, Betsy lived on this remote lake between the US and Canada, trapping, fishing, hunting and guiding fishing parties. She built her own cabin and traveled miles on foot and by boat for supplies, all without the luxuries of electricity or running water. The remarkable woman used her skills to survive, adapt and thrive on this lake, which is now a part of the Boundary Waters Canoe Area Wilderness.</p>

Betsy and Saganaga: One Life, One Lake

Biographies & Memoirs

Memoirs

Adventure Publications

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Books by DeSain, Carol