Simplifying Global Compliance
If you manufacture drugs for sale in the EU, beware. Your own computers may be setting a trap for you. Computer validation is the issue. Just when you think you've got the FDA's requirements figured out, the EU issues its own. This book shows you how they differ.
Just released from FDAnews - Investigations Operations Manual 2013 - the FDA's own internal guidance on how to inspect a drug or device company.
Guide to Global Clinical Trial Inspection Trends, is a surprising review of clinical investigator inspections, is based on 12 years of research by Dr. Johan Karlberg, founder and editor of The Clinical Trial Magnifier, a weekly report on globalization of clinical research.
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