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.
This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.
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.