CAPA/Root Cause Analysis: Achieving Compliance with Proper CAPA Systems

This webinar will include discussions on proper CAPA system maintenance, root cause analysis, documentation of the Corrective and Preventative Actions, and developing a robust CAPA plan. It will give tips on how to develop CAPAs pertaining to longer-term projects and ensure they stay on track.

• Discuss what to do when problems occur
• Outline the requirements of the CAPA process and procedure including building a CAPA file
• Choose the most appropriate Root Cause Analysis methods for the situation
• Establishing a CAPA plan: project summary, individual responsibilities, and expected completion dates
• Management and Oversight of the CAPA system and its documentation

Definition of a CAPA:

• When a CAPA is needed
• Development of the essential pieces of a robust CAPA plan

Root Cause Analysis Methods:

• Discussion of different Root Cause Analysis methods and benefits of each

Establishment of the CAPA Plan:

• Project Summary development
• Responsibilities of individuals involved
• Establishing Completion Dates
• Creating meaningful effectiveness checks

Management of the CAPA System:

• Maintaining proper documentation of the CAPA plans
• Ensuring CAPA plans are progressing
• Proper close-out of CAPA plans

• Quality Control Personnel & Management
• Manufacturing Personnel & Management
• Senior Management
• Regulatory Affairs Personnel & Management
• Quality Assurance Personnel & Management
• Supplier Quality Personnel & Management

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.