Free FDA GMP / QSR Ebooks for IPhone, IPad, Blackberry & Other E-Reader Devices
Aren’t the IPhone and the IPad great?? All of the information you could possibly want, right there at your fingertips! As Quality & Compliance professionals, we often need to reference a section or two in the regulations. Remember the “little regulation books” you were handed as a raw recruit so many years ago? Well, now we are in the 21st Century! As a service to FDA-regulated industry, we are providing E-Book formats for three of the main published FDA regulations for pharmaceuticals, dietary supplements and medical devices. (More to come soon!!) As such, the following are links to the first installment of FDA regulations in Ebook format that you can have for free on your IPhone or IPad.
Let’s get started:
First, you have to install on your IPhone or IPad (or other compatible cell phone/PDA) the free E-book reader, Stanza, which is a free download, from ITunes or directly from your IPhone or IPad using the App Store Icon. Also, if you are using a Blackberry or other smartphone, you can download Stanza or another similar free EBook reader (like Mobipocket) from your own App store, or from the respective program websites. NOTE: The EBook reader must work with the .EPUB format.
Second, for users with the IPhone or IPad, visit this same blog post using Safari with your IPhone or IPad. Just enter www.compliancearchitects.com/CABlog/ into the Safari address bar.
Third, when this post comes up in your browser on your IPhone or IPad, click on each of the following links, and that will launch Stanza and bring the regulations right into your Stanza library! Come back and get the next one when you want / need. It’s that simple!
Dietary Supplement GMPs (21 CFR 111) Ebook
Pharmaceutical GMPs (21CFR 211) Ebook
Medical Device Quality System Regulation (21 CFR 820) Ebook
Human Food GMPs (21 CFR 110) Ebook
Electronic Records/Electronic Signatures (21 CFR Part 11) Ebook
If you have a Blackberry or other smartphone, and you use a different reader than Stanza, use the following links to download the file directly and load it onto your device (right-click on the link and save on your computer):
Dietary Supplement GMPs (21 CFR 111) Ebook
Pharmaceutical GMPs (21CFR 211) Ebook
Medical Device Quality System Regulation (21 CFR 820) Ebook
Human Food GMPs (21 CFR 110) Ebook
Electronic Records/Electronic Signatures (21 CFR Part 11) Ebook
Please consider registering with our site to be notified of new, upcoming EBooks and articles of interest. We will use this to keep you abreast new quality, regulatory and compliance information.
What other reference documents would you like to see in this EBook format? Please let us know, and we’ll try to get them developed and out to you ASAP!
We hope you find this useful, and if you like this, please send us a note (or consider giving us a call for your compliance advisory and consulting needs!). Enjoy!
© 2010, Jack Garvey, Principal, Compliance Architects LLC. All rights reserved. On republishing this post, you must provide a link to the original post.




























Hello,
Thank you for offering these helpful ebooks for free.
I tried to open the ebooks in two different computers through mobipocket, but they could not be opened. There may be something wrong with how the files were created. If you are able to identify and fix the problem, kindly let me know so I can download the fixed files.
Sincerely,
Jhoanna
Jhoanna, My apologies. I have an IPhone and have NOT verified the ability to use the .EPUB format with Mobipocket on the Blackberry. I went with the .EPUB format because it worked on the IPhone and was “open standard.” Check out this link http://www.labnol.org/software/blackberry-ebook-readers/8386/ which may help with the Mobipocket / Blackberry issue. I know it works on the Iphone!
I hope this is helpful.
please add 21CFR 312 and 314 (IND and Post Market Safety Reporting)
I don’t have a blackberry or Iphone but thought that this is an interesting program and would like to check it out. How easy is it to perform a search function using keywords?
Using Stanza on the IPhone, it’s very easy. Each of the documents have full search capability, so you can search by any term and a list of links to the places where that term is found are presented. Very user friendly.