Weinberg Good Laboratory Practice Regulations, Fourth Edition

4. Auflage 2013
ISBN: 978-0-8493-7584-2
Verlag: Taylor & Francis
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 304 Seiten

Reihe: Drugs and the Pharmaceutical Sciences

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Zielgruppe

Laboratory compliance managers and other compliance professionals in pharmaceutical, biotechnology, and medical device companies; pharmaceutical scientists and researchers in all laboratory settings; and regulatory affairs professionals in pharmaceutical, biotechnology, and medical device companies.

Autoren/Hrsg.

Weinberg, Sandy

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie

Inhaltsverzeichnis

Historical Perspective.  FDA/GLP Regulations.  Applying 21 CFR Part 11 to the Laboratory Environment.  The Good Automated Laboratory Practices.  Implementing GLPs in a Non-GLP Analytical Laboratory.  Controlling the GLP Inspection Process.  Computer Systems Validation.  GLP Documentation.  The FDA’s GLP Inspection Program.  The Future of Good Laboratory Practice Regulations