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.

AREA COVERED

• 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

• Benefits: 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.
• Complimentary Hand-outs (other than ppt slides): For e.g. checklists, process documents, flow charts, pdf or docs of supplementary reading material, etc.

WHO WILL BENEFIT?

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