Tom Weaver, President, Weaver Consulting
Tom Weaver, President, Weaver Consulting
CAPA Corner

Step 2 – Another Key Investment for Success with a Root Cause Investigation

By Tom Weaver
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In this third of a series of articles on conducting a root cause investigation, we explore a second key investment every investigator should make: assuring you have the facts! Unfortunately, investigators are often under tremendous pressure to complete the investigation and assume the information they have is entirely correct. As a result days, or weeks, are wasted going down the wrong path.

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Tom Weaver, President, Weaver Consulting
Tom Weaver, President, Weaver Consulting
CAPA Corner

Model for a CAPA Root Cause Investigation

By Tom Weaver
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This is the first of a series of articles on conducting a root cause investigation. The model applies to a Corrective Action/ Preventive Action or CAPA investigation, as well as any other type of investigation. In this premier article, we describe a model for conducting a science-based, systematic investigation leaving future articles to delve into more detail as the individual steps are explored, specific tools are highlighted, and example investigations are reviewed.

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

IVDD – Article 4

By Dr. Christopher Joseph Devine
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This edition has two important takeaways: one, without a CE mark, the device cannot enter into commerce in the EEC; and two, the language requirement will continue to be a big challenge for device manufacturers as more countries opt to have labeling and IFUs in their native tongues.

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