How to properly investigate OOS/OOT Results

Overview

The speaker will provide sound training on how to recognize and investigate atypical or out of specification results, using approaches which have been recommended by regulatory authorities, performing appropriate investigations.

This webinar will review the regulatory requirements for investigating an OOS Investigation.

The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.

Why Should You Attend

The lack of or Inadequate procedures for handling out of specification (OOS) situations and failure investigations are amongst the most frequently found deviations in FDA warning letters.

Most companies have procedures but either they are not adequate or are not followed. This seminar will guide attendees through the entire process from detection an out-of-specification result to informal and formal laboratory and batch investigations

Areas Covered in this Webinar

• FDA requirements for handling OOS/ OOT results
• Phase I- Laboratory Phase of Investigations
• Phase II a Full Scale Investigation
• Concluding an Investigation
• Out-of Trend investigations
• Common pitfalls during OOS Investigations
• Review of recent OOS related citations in Warning Letters

Learning Objectives

• Learn the responsibilities of Analysts and Supervisors
• Listen to what the FDA looks for in terms of Human Errors
• Describe when a Full Investigation should be triggered
• Describe the frequency for Re-testing and Re-sampling
• Learn how to implement the corrective and preventive action plans (CAPA)

Who Will Benefit

• Quality Assurance/Quality Control Directors, Managers, and Specialists
• Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists
• Quality Control Laboratory Staff

Others Details

For more details and updates please visit webinar website