Investigating OOS Results

Pre Recorded

  • 60 minutes

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 webinar will guide attendees through the entire process from detection an out-of-specification result to the informal and formal laboratory and batch investigations. 

In this webinar join expert speaker Danielle Delucy, where participants will learn the origin of the term out of specification and FDA concerns and opinions. They will be led through a process for the successful completion of OOS investigations. 

Session Highlights: 

  • 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 

Why You Should Attend:

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. 

Who Should Attend:

  • QA managers and personnel

  • Analysts and lab managers

  • CAPA management 

  • Regulatory affairs 

  • Training departments

*You may ask your Question directly to our expert during the Q&A session. 

** You can buy On-Demand and view it as per your convenience.

Danielle  Delucy

Danielle Delucy

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 17 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations.  

Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients.  In the years after, she has held positions in the Quality management arena while increasing her responsibility.  She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed. 

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