Tag Archives: 21 CFR

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Quality Audits

By Dr. Christopher Joseph Devine
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Dr. Christopher Joseph Devine, President, Devine Guidance International

The Food and Drug Administration (FDA) will evaluate the effectiveness of your internal quality audits and review the corrective actions pursued as part of the overall quality audit system. If a nefarious approach to executing quality audits is pursued, the reward will be a Form 483. If the FDA feels the violation is egregious, a warning letter will be forthcoming. In monopoly speak, “do not pass go and do not collect your two hundred dollars.” Warning letter violations As you can see by the abundance o…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Management Responsibility

By Dr. Christopher Joseph Devine
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Dr. Christopher Joseph Devine, President, Devine Guidance International

I begin this edition of Devine Guidance  (DG) by reinforcing the importance of DG Rule #1 – Compliance to regulations is not optional, compliance is mandatory and dictated by law. In my belief, management responsibility is what the doctor likes to call the “catch-all requirement.” What does that mean Dr. D? Simply put, if your organization fails to comply with any part of the QSR, rest assured, the reward will be in the form of a Form 483 for the specific transgression, by the agency. Additionally,…

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