Life Sciences

The Difference Between Corrective And Preventive Action

Difference-Between-Corrective-And-Preventive-Action

 

We recently discussed what CAPA means and why it’s important. Since many people in our field express confusion between the “CA” and the “PA,” I’ll quickly explain the difference between corrective action and preventive action.

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To put it simply, a corrective action can be defined as specific steps taken to address observed non-conformities or undesirable events, while a preventive action can be defined as specific steps taken to address potential non-conformities or undesirable events. 

Below is an example of a CAPA that was taken from this FDA presentation:

Issue: Incorrect dosing (overdoses) contributed to AEs/SAEs observed in subjects

Example of CAPAs:

  • Reinforce training for monitors/site staff
  • Amend protocols to further clarify dosing instructions
  • Add additional instructions on investigational medication itself

To read other posts in our “Argus Safety for CAPAs” series, click here.

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Rodney Lemery

Dr. Rodney Lemery specializes in the implementation, support, and development of software used in the collection, management, and analysis of clinical data. His accomplishments as director of safety and pharmacovigilance at Perficient include the management of numerous clinical application implementation projects. In addition to his expertise in clinical and safety applications, Rodney is able to navigate between the technical and clinical worlds with ease due to his complementary educational background in epidemiology. He also holds a part-time professorship in the School of Health Sciences at Walden University, which solidifies his ability to lead global safety implementations at Perficient. Rodney has been with Perficient, via the acquisition of BioPharm Systems, since 2000. Prior to joining the company, he worked at Pfizer.

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