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Search Results for '21 CFR Part 11'

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Published June 26, 2013
Reporting hub designed to increase clinical trials operational visibility Read More »
ERP Selection
By Jay Deakins, Deacom
Published March 6, 2013
Considerations for pharma manufacturers Read More »
Published February 27, 2012
Title 21, Code of Federal Regulations, Part 11. Part 11 established the criteria under which electronic records and signatures will be considered equivalent to paper records and handwritten signatures in manufacturing processes regulated by the FDA.… Read More »
Published February 27, 2012
The U.S. regulations that directly apply to biopharmaceutical development are contained in Title 21 parts 58 (Good Laboratory Practice for Nonclinical Laboratory Studies), 210 (Current Good Manufacturing Practice in Manufacturing, Processing, Packing… Read More »
Published February 27, 2012
Hardware and software applications in which a company has already invested considerable time and money. Legacy systems typically perform critical operations in companies for many years even though they may no longer employ state-of-the-art technology… Read More »
By John Avellanet
Published September 7, 2011
Where is the FDA headed? Read More »
By Kristin Brooks
Published August 23, 2005
The risk-based revolution in IT Read More »
By Suggy S. Chrai
Published August 22, 2005
21CFR11 and process validation Read More »
Microbiological Testing & Contamination Control
By Daniel L. Prince, Ph. D., Christopher J. Waskewich, M.S., Kristah J. Kohan, B.S. and Danina G. Rinaldi, B.S. , Gibraltar Laboratories, Inc.
Published March 7, 2014
An opinion on the microbial limit test with reference to harmonization. Read More »
By Kyle Sampson, Hunton & Williams LLP
Published July 17, 2013
FDA encourages utilization of robust quality agreements with CMOs Read More »
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