How FDA Trains Its Investigators to Review CAPA, and What You Can 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.

Description 
This session will discuss what the FDA tells their inspectors, and how they train them, including a detailed analysis of the CAPA training. What should I expect the FDA investigator to look at when they visit? The FDA inspection can be much easier to handle and manage if you know what to expect. Advance knowledge will enable you to prepare for the FDA inspection. This knowledge and planning will make the inspection experience much less stressful, and assure better compliance.  

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.

Who will Benefit:

This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

• Executive/Senior Management
• Regulatory Management
• QA Management
• Any personnel who may have direct interaction with FDA officials
• Consultants
• Quality System Auditors