Faculty: Danielle DeLucy
This seminar 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.
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 in the Session :
Guidelines for Detecting an OOS or Atypical Result
Testing the hypotheses regarding potential root causes
Developing a proper CAPA plan to address any Corrective Actions
Who Should Attend: