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February 1, 2013
By:
R.D. McDowall
Answers to common questions about operational qualification software.
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November 1, 2012
By:
R.D. McDowall
Written procedures used by trained staff are the basis for all quality systems but there are many ways of writing a procedure. Are you getting it write?
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April 1, 2012
By:
R.D. McDowall
Mistakes or fat finger moments are part of human nature but where is the dividing line between this and falsification and fraud?
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February 1, 2012
By:
R.D. McDowall
The results of a recent survery on stationary phases used in high performance liquid chromatography (HPLC) are revealed.
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August 1, 2011
By:
Lukas Kaminski, Joachim Ermer, Claus Feuäner, Armin Groh, Heidemarie Höwer-Fritzen, Peter Link, Bernd Renger, Martin Tegtmeier, Hermann Wätzig, Robert D. McDowall
A look at the role of system suitability tests (SSTs) during performance qualification (PQ).
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April 1, 2011
By:
Bob McDowall
How will the new revision of EU GMP Annex 11 on Computerized Systems and Chapter 4 on Documentation affect chromatographers?
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December 1, 2010
By:
Bob McDowall
The concluding part of the series on the role of system suitability tests in the pharmaceutical industry.
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March 1, 2010
By:
Ruud J.P. Goedknegt
There is more to using and interpreting certificates for chromatography standards than meets the eye
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December 1, 2009
By:
R.D. McDowall
There is a new FDA Commissioner who wants a "strong FDA". Chromatographers must be prepared to be compliant and remain compliant — or else!
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