When Things Go Wrong: Managing Nonconformances, Investigations, and CAPAs

A 30-minute webinar for life science companies looking to strengthen how they manage nonconformances, investigations, and Corrective and Preventive Actions (CAPAs)

When something goes wrong, organizations must be able to identify the issue, understand its impact, determine why it occurred, and take appropriate action to prevent recurrence.

However, managing quality events involves more than documenting a problem and assigning a corrective action. Organizations must consistently evaluate nonconformances, conduct proportionate investigations, identify root causes, and determine when a CAPA is necessary.

Life science companies often encounter avoidable challenges when:

• nonconformances are not clearly documented or appropriately assessed,
• investigations focus on immediate symptoms rather than underlying causes, or
• CAPAs are initiated without clear actions, responsibilities, timelines, and effectiveness checks.

In this webinar, we will explore how nonconformances, investigations, and CAPAs work together and discuss how companies can establish a structured process for managing quality events from initial identification through resolution.

The session will focus on:

• identifying and documenting nonconformances,
• assessing impact, risk, and the need for further investigation,
• conducting structured investigations and determining root causes,
• understanding when a CAPA should be initiated,
• defining corrective and preventive actions, responsibilities, and timelines, and
• verifying CAPA effectiveness before closure.

Nonconformance management, investigations, and CAPA management will be discussed as interconnected elements of a complete Quality Management System that includes additional quality processes beyond the scope of this session.

This webinar is intended for life science organizations looking to establish, formalize, or improve their approach to managing nonconformances, investigations, and CAPAs.