Article Results (Showing 1 - 10 of 16) RSS Alert
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IPEC rolls out GMP auditing program for excipients
DENVER --- The International Pharmaceutical Excipients Council of the Americas (IPEC) is rolling out its voluntary standards and requirements for...
Validation Times, 12/01/01 by Dan Whipple · More from publication -
AAPS to present FDA with paper on ligand-binding assays
DENVER - A special committee of the American Assn. of Pharma-ceutical Scientists (AAPS) is preparing a white paper to assist FDA in setting...
Validation Times, 11/01/01 by Dan Whipple · More from publication -
53% say validation doesn't improve instruments, only fits regulatory need, according to informal survey
DENVER --- An informal survey of analytical labs has found that more than 53% of respondents find relatively little value in validation, and even...
Validation Times, 11/01/01 by Dan Whipple · More from publication -
Stability Over 26% of NDAs lack stability data; Q1A helps little
DENVER The International Conference on Harmonization's (ICH) Q1A guidance and recent revisions regarding stability has helped define and...
Validation Times, 07/01/01 by Dan Whipple · More from publication -
Electronic 'tagging' for record changes seen as FDA desire
DENVER In a change that is evident in guidance documents, but not in the 1997 electronic signature/records regulations (21 CFR Part 11), FDA is...
Validation Times, 07/01/01 by Dan Whipple · More from publication -
FDAer says firms should go beyond 'functional testing'
DENVER Manufacturers of therapeutic products need to look at software validation broader because FDA is not satisfied industry is going as deeply...
Validation Times, 07/01/01 by Dan Whipple · More from publication -
Fire storms.(featuring the National Center for Atmospheric Research's wildfire detection system)
A New Computer Model is Providing Clues to the Secrets of Wildfires There are a lot of unexpected things to be learned by flying an airplane...
Weatherwise, 07/01/99 by Whipple, Dan · More from publication -
Can parks sell Mother Nature?
Yellowstone is home to heat-loving microbes of enormous commercial value. To assure a share of this bounty, the park is pursuing `bioprospecting'...
Insight on the News, 12/08/97 by Dan Whipple · More from publication -
Scientists claim future of Earth depends on ecosystem diversity
Ecologists and policymakers from around the world will convene in Washington in late October to discuss the issue of biodiversity and other...
Insight on the News, 11/03/97 by Dan Whipple · More from publication -
Can't see forest for lack of trees: will legislation to reform forest management satisfy timber cutters and conservationists?
The Senate subcommittee on Forests and Public Land Management has developed legislation to reform and improve the management of national forests. A...
Insight on the News, 01/06/97 by Dan Whipple · More from publication
