Home » FDA Plans to Emphasize Metrics, Not Documentation, in Inspections: CDER Director
FDA Plans to Emphasize Metrics, Not Documentation, in Inspections: CDER Director
The FDA plans to shift its focus during facility inspections away from examining documentation, such as standard operating procedures, and place more emphasis on a facility’s operational metrics. “We really want to know more about the results,” not the design, of a facility’s quality system, CDER Director Janet Woodcock said Monday.
Drug Industry Daily
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