Properly Investigating and Remediating OOS Results

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.

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.

• 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:

• FDA and other regulation expectations with regard to OOS investigations
• Development of an efficient and compliant procedure for failure investigations
• When and what to retest?
• How to properly document the OOS investigation?
• How to develop a corrective and preventive action plan?

• QA managers and personnel
• Analysts and lab managers
• CAPA management
• Regulatory affairs
• Training departments