Root Cause Analysis and CAPA Controls for a Compliant Quality System

In this CAPA webinar, learn various regulations governing Corrective and Preventive Actions (CAPA) and how organization should collect information, analyze information, identify, investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence.

Why Should You Attend:

As simple as it sounds, the Root Cause Analysis and CAPA has always posed challenges to the organization and has been the #1 reason for 483 observations and Warning Letters for the last 15 years. Strong CAPA controls make an organization compliant and less vulnerable to customer complaints, nonconformance, deviations, etc. The CAPA controls rely on three important concepts namely, remedial correction; understanding the root cause and come up with corrective actions; and to have preventive actions to avert recurrence. If the root cause analysis is not done correctly, all the subsequent steps towards correction and prevention would be rendered ineffective and cause the issue to reoccur.

You will learn insights into root cause analysis and develop a logical approach to problem solving by accurately identifying causes of problems and have permanent solutions in place. This would help drive compliance and towards an organizational success.

Areas Covered in the Webinar:

• Introduction to include background, key definitions, and FDA, ICH, and ISO requirements
• Quality System Inspection Techniques (QSIT), Nonconformity and CAPA Inputs
• Root Cause Analysis tools: 8-Disciplines (or 8D), 5 Whys, Fishbone (Ishikawa) Diagram and Brainstorming
• Examples of RCA and CAPA
• Risk based approach FDA 483s and Warning Letters

Who Will Benefit:

• QA/QC Managers
• Operations Manager
• CAPA Managers
• Quality Engineers
• Management Representative
• Internal Auditors
• Training Manager