This message is sent to you by FDA Newswatch

Properly Investigating and Remediating OOS Results

November 17, 8:00 AM PST | 11:00 PM EST| Duration: 90 Min

Sponsored by ComplianceOnline

Click Here to register $249.00

Click Here to register and receive  recording $529.00

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.


Areas Covered in the Webinar:

  • 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

Instructor Profile:

Danielle DeLucy
Owner, ASA Training and Consulting, LLC

Danielle DeLucy, MS, is currently an independent consultant to the biologics and pharmaceutical industries specializing in the areas of quality assurance and quality systems.

Prior to this role, Ms. DeLucy 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.