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Document library
CFR – Code of Federal Regulations
CPG – Compliance Policy Guides
FR – Federal Register
GFI – Guidance for Industry
Most abbreviations can be found in the “Acronyms and Abbreviations” (Glossary) section.
Document search
You can search with one or more words.
The result will show documents where the search words are present, both as whole words or as a part of a word (e.g. valid will show both valid, validation, validated etc.)
You can not use search operators as dubbel quotes, question marks or asterisks.
The PDF documents are protected from changes and copying but can be printed in high resolution.
Right-click in the text and choose “Search (Simple)” or Ctrl+F. (The word is highlighted in the text and you can scroll forward/back)
For an advanced search, choose “Edit” > “Advanced search” or Shift+Ctrl+F (The result is presented as a list in the left column.)
Warning Letters
No WL:s regarding those paragraphs have been issued since 2006.
Interpretations 21 CFR 210/211 (Premium)
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If you have a valid subscription, please contact the Key2Compliance® customer service: info@key2compliance.com
– A list of the interpretation documents for this paragraph will appear.
– Click on a document link to open the Interpretation summary.
– Click on the “Open PDF” button to open a printable pdf with the summary and an excerpt from the document. The relevant text in the excerpt is marked in yellow.
Glossary
We are always happy to expand the glossary. Please send an e-mail with a suggestion and we will consider if it is suitable to add.
Links
Please send an e-mail with the link name and we will fix it asap.
Premium
There are several free EPUB reader apps for the most common platforms (Windows, Mac, iOS and Android).
Search in your app store and install on the device where you have downloaded the EPUB file and open it from there.
Recommended apps
Mac or iPhone: iBook (std app)
Android: Moon+ Reader ; eReader Prestigio
Windows: Calibre ; Freda
The EPUB format is adapting to the screen size (free flowing text).
The books have an index with links and a seach function.
Events
Please send an e-mail with all the data and we will consider if it is suitable to add.
Note. It must be an event connected to GMP or Quality system knowledge.
Key2Compliance® alumni
If you have attended a public Key2Compliance® course after March 1st, 2014 you should have access. If not, please contact the Key2Compliance® customer service: info@key2compliance.com
Advertising
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Error reporting
We are very greatful for all reports on malfunctions.
Please send an e-mail with a short notice on what is wrong and we will fix it asap.