Tag Archives: medical device summit

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

The Training Tradeoff – Trained Employees that Leave versus Untrained Employees that Remain

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

One concern we frequently hear is absorbing the expense associated with training and then key employees departing the organization for greener pastures after their training has been completed. But what about the costs associated with mistakes and errors employees make, when employees are not properly trained and decide to stick around?

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

Maybe 13 is an Unlucky Number

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

In the United States, to manufacture and/or enter devices into commerce, device establishments are expected to have written procedures that are fully implemented and in compliance with the QSR and subsidiary regulations. Do not be that organization that receives 13 Form 483 observations because procedures have not been established.

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

Data Falsification

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

Whenever phrases such as “data falsification” are referenced by FDA in a warning, the offending organization will probably become familiar with the acronym DOJ, as in investigation. Falsifying data that may have resulted in the overall compromising of product safety and efficacy is a serious accusation.

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