Corrective And Preventative Action Plan

Good example of a CAPA as noted in a CRA report. Since the CRA is the “site manager”, a CAPA that corrects an issue/problem at a site, is also a CAPA that fulfills the CRA requirement therefore making it both the site and CRA CAPA: Subject BCD/234 Visit 3 labs were drawn after the drug administration. The protocol section 5.2 requires the labs to be drawn before administration. The investigator stated the cause of the deviation was due to a different staff member covering for the research coordinator. The investigator noted a new policy would be developed within 48 hours to cross train new employees prior to working on a study.  Create your own CAPA for any ONE issue identified in an actual Warning Letter supplied by the FDA to an investigator. The link to FDA issued Warning letter appears here:   (Links to an external site.) . Provide the link to the letter you chose in your post.  (Links to an external site.)  Identify which issue you are writing the CAPA for (from the letter and only one issue from the letter requires a CAPA for this DB) and write a CAPA as a monitor reviewing the site’s corrective and preventative action plan at the visit that follows the FDA’s visit to the site.  (We are making the assumption for the purposes of this assignment that the investigator has created a CAPA).  (At minimum this should be one paragraph; 5 – 7 sentences to receive full points).

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