Tag Archives: Statistical Techniques

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

Statistical Techniques

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

This week’s Devine Guidance on 21 CFR, Part 820 – Subpart O (Statistical Techniques) is the proverbial “Final Act” in regards to the QSR. There is a plethora of data, standards, and websites that can provide useful information needed to create robust procedure(s) for establishing effective statistical control and sampling plans. Establishing robust statistical procedures will mitigate the potential receipt of a Form 483.

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