Effective Application of CAPA using a Risk-Based Approach
Overview:
It is imperative to apply CAPA at a level commensurate with the risk to the product quality resulting from the failure being addressed. A formal CAPA process must not be applied without a risk assessment of the event/system failure and the level of detail/depth during the investigation must correlate with the risk level to the product quality also considering the probability of re-occurrence and the detection capabilities if the event or failure should occur again. This session will address how to apply different levels of the CAPA process corresponding to the risk being addressed.
Why should you attend: The lack of or ineffective CAPA Implementation is still one of the most common issues found by the FDA during their inspections due to the lack of structure and incorrect approach used by the companies. Many of them are applying CAPA to every deviation as just a paper completion process without understanding the true meaning of the CAPA concept.
Course Modules & Content Details:
- Elements of a CAPA procedure:
- Definitions
- Systems to trigger CAPA:Procedure deviations, OOS, Internal/External Audits, Documentation errors, Customer Complaint system, Reworks/Reprocessing data, others.
- Criteria to apply CAPA - reoccurrence, criticality, impact on product quality or process controls
- Determination of a risk-based categorization for each CAPA to address the level of detail/formality of the evaluation process
- Analysis of the CAPA and How to Apply Quality Risk Management:
- Corrective - Root cause analysis with corrective action to prevent recurrence - establish detail based on the risk-based levels
- Preventive action to prevent initial occurrence - establish detail based on the risk-based levels
- How to identify corrective and preventive actions
- How to verify/validate that the corrective /preventive actions have been effective applying the risk levels to determine the extent of the verification
- Communication - management reports
Who Will Benefit:
- Manufacturing
- R&D
- Quality
- Validation
- Engineering
- Top Management