Don’t Let Poor Training Records Derail Your FDA Compliance

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21 CFR 211.25 specifies employee training and education must have “sufficient frequency to assure that […]

Are you properly initiating your CAPA Procedure BEFORE taking Corrective Action? 

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A robust corrective and preventive action (CAPA) system is critical for maintaining compliance and product […]

Are You Properly Storing Batch Records?

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A recent FDA inspection at a pharmaceutical manufacturing facility revealed serious deficiencies in the firm’s […]