How to properly investigate OOS/OOT Results


Danielle DeLucy, MS, is Keynote speaker at Compliance Key, Inc. She 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, 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 Micr........

Overview

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 this webinar?

The lack of or Inadequate procedures for handling out of specification (OOS) situations and
failure investigations are among 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 in the Session:

Who can Benefit:



Webinar Id: LSHCDD0001

Training Options:

Duration: 60 mins

 View anytime

 Recorded: [Six month unlimited access]

 $167 (Single Attendee)  $599 (Unlimited Attendee)

Refund Policy
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