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21 CFR Part 11 Lookup:

11.1.pdf
11.10.pdf
11.100.pdf
11.2.pdf
11.200.pdf
11.3.pdf
11.30.pdf
11.300.pdf
11.50.pdf
11.70.pdf

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FDARegulatory.com provides a collection of resources and FDA regulations which outlines ethical and scientific quality standards for designing and conducting operations in an FDA regulated environment.  Here you will find information about the U.S. Food and Drug Administration (FDA) and how their regulations protect the ultimate consumer of products produced within the FDA-regulated industries. Mandatory standards (or regulations) are based on the United States Code; collectively, these standards make up the Code of Federal Regulations (CFR). Most of us who have just been introduced to regulations are familiar with 21 CFR Part 11.  However, be reminded that a very important predicate rule of the CFRs is section 820.25 which outlines the importance and requirement for highly trained personnel.  This is part of Good Manufacturing Practices (  GMP / cGMP ) and all other GxPs inlcluding Good Clinical Practices ( GCP ) and Good Laboratory Practices ( GLP ).

Start preparing yourself for your responsibilities or keep your current skills sharp!  Our library and list of books regulatory compliance has been compiled from a variety of sources, including top regulatory experts in the industry.  

Take me to the Bookstore for more FDA Compliance books!  

Need validation consultants ?  Try the following validation specialty firms to help you:

• Validation and Compliance Institute, LLC
• David Nettleton Part 11, HIPAA, Validation consultant
• Phoenix Consultants
• David Begg Associates
• Rocky Mountain Compliance Specialists, Inc
• PharmaReady™
• FDA Compliance Helpdesk

The help of specialists like those listed above, training, and a compliance facility helps assure the consumer that their well-being is protected and ensures that clinical trial, packaging and/or laboratory data are credible.  Understanding of these regulations is critical to anyone employed in such an environment. The CFRs and industry guidelines represent a minimum set of requirements for the industry to follow in order to produce a reliable and reproducible product or service throughout the product development lifecycle - so training and having proper reading materials are key!  FDARegulatory.com's selected books illustrate different aspects of complying with regulations.

In addition to purchasing books, please take advantage of our comprehensive library of information and reference papers to help provide you with the education and proficiency you need to meet FDA training requirements. 820.25 states that continued education is required and our goal at FDARegulatory.com is to provide the necessary resources to do so.