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The GMP Letter (GMP) is your key to staying on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes must be made to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.
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PLUS, you get links to key documents acquired by the FDAnews editorial staff, including actual 483s, warning letters, closeout letters, guidances, FDA notices, and many others.
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