Root cause identification is an expectation of FDA and other regulatory agencies, and is one of the most frequently cited problems during regulatory inspections.  Many companies do not understand the difference between direct causes and root causes of issues, which lead to weak, inappropriate, or ineffective corrective and preventative actions (CAPAs).  Even more companies understand the differences, but are not using an effective process that enables success.

_{^{Who Should Attend}}

• Quality, Validation, Manufacturing, and Management personnel from sponsors and contract manufacturers (CMO) alike.

_^Outlines

• Awareness of the Investigation Process
• Regulatory Expectations for Investigations
• Investigation Process Overview
• Skills and Tools of an Effective Investigator
• Introduction to Root Cause Analysis (RCA)
• Identifying Root Cause Process
• Corrective and Preventive Actions (CAPA)
• Handling Out of Specification
• Case Studies