Effective Investigation of Out of Specification, Out of Trend or Atypical Results

This course is designed to provide sound training on how to recognize and address atypical or out of specification results, using approaches which have been recommended by regulatory authorities. It also informs participants how to perform investigations to assure both compliance and good business decisions.

Course Overview

1. Assessment of Attendees Backgrounds and Interests.
2. The FDA Guidance for Industry on Investigating OOS Test Results.
3. Conducting the Investigation.
4. Evaluating the Outcomes: Has the Root Cause been identified?
5. Documenting the Investigation.
6. Case Studies.
7. Interactive Workshop: Participants’ Examples.
8. CAPA.
9. Utilizing Outcomes for Continuous Improvement.
10. Questions and Discussions.

Learning Objectives

• Recognize the drivers to address investigations effectively.
• How to complete investigations faster and with less stress.
• Tools for finding the Root Cause: brainstorming, risk assessment, hypothesis testing.
• The critical link between Root Cause Analysis and CAPA.
• Making sure CAPA has really addressed the issue.

Cancellation Policy

Cancellation or rescheduling must be made within 10 business days prior to the start of the course to avoid a 50% billing fee to the attendee.  A one-day cancellation or no-attendance will result in full billing.

Distek, Inc. reserves the right to cancel any course 10 business days prior to the course where the minimum enrollment is not met.  The purchase of non-refundable airline tickets is not recommended due to possible course cancellations.

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