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Regulatory Requirements for Conducting an OOS Investigation

28-November-2022 :01:00 PM EST Duration : 60 Minutes

Danielle DeLucy, Pharmaceuticals, Biotechnology

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, suc Read more


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.

Course Objectives:

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.

Course Outline:

• 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

What You Get:

• Training Materials
• Live Q&A Session with the Speaker
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

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

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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