By Mark Durivage, Quality Systems Compliance LLC

Published in: Outsourced Pharma

Published on: March 9, 2020

Corrective and preventive action (CAPA) issues continue to be one of the top Form 483 observational findings by the FDA. Many times, CAPAs fail due to the structure and flow of the process and not necessarily the efforts of those managing the CAPAs. Frequently, organizations do not fully document the CAPA phases and confuse verification of implementation and verification of effectiveness activities. (For an introduction to the CAPA phases, read my previous article “The 10 Phases Of An Effective CAPA.”) This article will look at using the SMART (specific, measurable, achievable, relevant, and time-bound) methodology for use in developing a CAPA verification of effectiveness plan

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