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Properly Investigating and Remediating OOS Results

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Course Description:

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.

Hear from our Speaker

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:

  • 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?

Session Preview

Who will benefit?

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




Registration Options


Avail 12 months unlimited access for a single user.


Material shipped within 15 days post webinar completion & get life time access for unlimited participants.



Tags


Investigating OOS Results, Remediating OOS Results, OOS Results, OOT Results, OOS Investigation, FDA warning letters, Laboratory Investigation,OOS Investigation Pitfalls, OOS Investigation Documentation, CAPA,

Speaker Details

Danielle Delucy

Danielle Delucy

Pharmaceutical Expert

Danielle DeLucy, prior to this role has been in the industry for 13 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 Lancaster Laboratories, a contract laboratory where she performed various tests for their clients.  In the years

Refund Policy



Participants/Registrants for our live events, may cancel up to 72 hours prior to the start of the live session and ComplyArena will issue a letter of credit to be used towards any of ComplyArena's future events. The letter of credit will be valid for 12 months.

ComplyArena will process refund in cases where the event has been cancelled and is not rescheduled within 90 days from the original scheduled date of the webinar. In case if a live webinar is cancelled, participants/registrants may choose between recorded version of the course or a refund. Refunds will not be processed to participants who do not show up for the webinar. A webinar may be cancelled due to unavoidable circumstances, participants will be notified 24 hours before the scheduled start of the event. Contact us via email: admin@complyarena.com or call +1-888-222-5917 (Toll Free).