How to Perform a Thorough Root Cause Analysis and CAPA Development

Deviations and Non-conformances are enviable. The key is utilizing those events as an avenue to improve the overall quality system. Thorough Root Cause Analysis is essential to correcting and preventing issues. RCA is a systematic approach that utilizes quality tools to objectively identify factors that have resulted in or could contribute to a deviation.

Once the RCA identifies the factors that caused the event, proper generation of CAPA actions is critical to maintaining a healthy quality system. The regulatory agencies fully expect to see documented root cause analysis that resulted in both corrective and preventative actions.

Areas Covered in the Session :

Part 1 – How to Perform a Thorough Root Cause Analysis (RCA)

• Understand Regulatory and Industry Guidance
• What is Root Cause Analysis?
• When Should Root Cause Analysis be performed?
• Discuss several Root Cause Analysis Methodologies
• Discuss common errors that occur during RCA

Part 2 – Developing Appropriate Corrective and Prevention Actions (CAPA)

• Understand Regulatory and Industry Guidance
• Discuss the difference between Correction, Corrective Action, and Preventive Actions
• Understand How to Develop robust CAPA records; including effectiveness checks

Part 3 – Review Real Life Case Studies

• Discuss recent Regulatory observations in regards to insufficient investigations and CAPAs records

Who Should Attend:

• Research and Development Departments
• Quality Assurance Departments
• Quality Control Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Facilities Teams

Course Director: KELLY THOMAS

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation. Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.