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Written by Hyltoft Petersen
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In the US, when it comes to quality requirements, we have CLIA and clinical decision criteria and a whole host of other choices (many of them bad). But, if you can believe it, the situation in Europe is even more complicated! Dr. Per Hyltoft-Petersen discusses external quality assurance schemes, ISO, analytical goal-setting, and finally biological goal-setting.
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Written by Sharon S. Ehrmeyer, Ph.D.
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Dr. Sharon Ehrmeyer returns with an section for our Basic QC Practices series. If you're operating a laboratory in the U.S., there's a government agency out there that wants to regulate you - do you know which one? In this article, Dr. Ehrmeyer details all the various bureaucracies and their regulations. See which rules apply to you!
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Written by Dr. Pharm J.C. Libeer, Ph.D. Ph.D.
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Dr J.C. Libeer, Ph.D., Ph.D, joins us from Belgium, where he has put together a comprehensive survey of the European quality schemes and programmes, noting their strengths and weaknesses. A must for those who want to learn about and keep current with laboratory quality management in Europe.
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Written by Karen Surkin, Donna Hershberger, and David Plaut
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Guest authors use QC Design software to customize their QC procedures for their laboratories.
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Written by Sharon S. Ehrmeyer, Ph.D.
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Dr. Sharon Ehrmeyer is back again! You may remember her article on regulations in our Basic QC Practices series. In this article, she explains which regulations and standards and agencies are involved with Method Validation. A must-read reference.
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