Successful Implementation 2021 - Properly Managing CAPA Programs for Successful Implementation

Many individuals find developing and managing an effective CAPA very challenging. Often, inadequate root cause analyses lead to ineffective solutions that fail to prevent a recurrence of the deviation.
FDA personnel are aware of these challenges and routinely audit such programs as a part of a regulatory inspection. Such deficiencies can result in 483 observations or worse, product recalls.
Speaker:
Danielle DeLucy, MS, is currently an Independent Consultant to the Biologics and Pharmaceutical Industries specializing in the areas of Quality Assurance and Quality Systems.