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Search Results for '21 CFR Part 11'

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Published August 6, 2013
STABILITY STUDIES From study design to storage and shelf life stability, to monitoring, analytical testing and documentation, SGS offers comprehensive stability testing services. With more than 20 years’ experience and currently more tha… 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 »
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 September 5, 2013
FDA adopts case-by-case approach for opioid analgesics Read More »
By Kyle Sampson, Hunton & Williams LLP
Published July 17, 2013
FDA encourages utilization of robust quality agreements with CMOs Read More »
By Heather Banuelos, Hunton & Williams LLP
Published May 6, 2013
DOJ to pursue enforcement Read More »
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