How FDA trains its investigators to review CAPA (FDA compliance program guidance manuals, QSIT manual) and what should you do to prepare

This CAPA investigation training webinar will discuss FDA’s techniques to do CAPA inspection, what the FDA tells their inspectors to focus in the QSIT document and how your company can use the QSIT document to prepare for inspection.

Areas Covered in the seminar:

• How to prepare for an FDA inspection?
• Development and contents of an SOP for FDA inspection.
• Reliance of FDA inspectors on compliance program guide manuals.
• Reliance of FDA inspectors on other external sources.
• Personnel training before inspection.
• In depth review and summary of QSIT.
• Use of QSIT for internal auditing.

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