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Thompson Interactive - GMP Internal Audits: How To Ensure Compliance

May 6, 2009 • Audio Conference Recording

“You state in your July 10, 2008 response that your firm continues to undergo annual external audits with the most recent audit conducted [(b)(4)] Our last inspection conducted in June 2008 and your firm's compliance history raise concerns about the effectiveness of the audits.”

The FDA is clear in this, and in other warning letters issued during the last year: “It is your responsibility to conduct a comprehensive audit of your facility and operations and assure compliance with all requirements.”

Of course, you have an internal audit program in place. But are you sure you have everything covered? Are you sure you won’t receive a 483 in spite of your audit program? Are you catching deviations before products leave the facility? In this 90 minute audio conference, FDA veteran Steve Niedelman and expert attorney Cathy Burgess will provide insight on internal auditing for compliance, and how to ensure your firm consistently produces and distributes high quality pharmaceutical products.

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