Our
Price: $ 124.95
Hardcover - 180 pages
Advanstar
Communications, Inc.; ISBN: 0929870395
Amazon.com
Sales Rank: 60,727
Book Description
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.
From the Inside Flap
Documentation Practices: A complete guide to
document development and management for GMP and ISO
9000 compliant industries includes everything you
ever needed, or wanted, to know about documents and
document management systems. It provides an accurate
and meaningful understanding of manual document
management requirements; features complete coverage
of documents, documentation, document management, and
document systems; and includes specific examples of
Commitment Documents, Directive Documents, and Data
Collection Documents.
The information Documentation Practices provides
will help the inexperienced reader understand the
purpose of documents and documentation; will aide the
experienced reader in designing new electronic
documents, databases, and management systems; and
will provide both with valuable insights when
existing systems begin to fail.
From the Back Cover
Documentation Practices demystifies the
documentation process and provides an accurate and
meaningful understanding of manual document
management requirements. It includes comprehensive
information about documents, documentation, document
management, and document systems, and it features
specific examples of Commitment Documents, Directive
Documents, and Data Collection Documents. The
knowledge this book provides will minimize the number
of documents required to achieve compliance and will
help in designing electronic documents, databases,
and management systems in the future.
About the Author
Carol DeSain is an independent consultant with 22
years' experience in product development,
manufacturing, and quality control, and specific
expertise in the design and implementation of QA
documentation systems.
Charmaine Vercimak Sutton is an independent
consultant to medical product manufacturers,
providing services in product development, clinical
design and management, quality system development and
implementation and regulatory compliance to meet FDA
expectations.
Together, DeSain and Sutton provide GMP regulatory
consulting for drug, device, and biologics
manufacturers through their Tofte, Minnesota-based
company, The Tamarack Group.
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