(FDAnews: Falls Church, VA) -- FDAnews and LearningPlus are presenting an interactive workshop, From Training to Learning: Improving GMP Performance, to be held Oct. 26–27, 2011 in Raleigh, North Carolina.
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Click here to register and for further details.
Although there are more than 20 references to training within the Food and Drug Administration's (FDA) Good Manufacturing Practice (GMP) regulations, the vagueness of the requirements is a constant source of confusion for companies, their training officers, and their employees.
21 CFR 211.25 states: “Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions.”
While this appears clear, companies continually fall short in their employee training. Recently, the FDA has issued more than 40 warning letters citing inadequate employee GMP training.
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