Create Great Out-Of-Specification (OOS) Procedures

Event Information
Product Format
Prerecorded Event
Conference Date
Tue, Jun 12, 2018
60 minutes
Product Description

What To Do When You Detect an OOS Result

Missing or inadequate procedures for handling out of specification (OOS) situations and failure investigations are amongst the most frequently found deviations in warning letters from the U.S. Food and Drug Administration (FDA). While most companies do have procedures in place, these are not adequate—or are not followed.

Join pharmaceutical consultant Danielle DeLucy in this live webinar as she guides you through the entire process from detection of an out-of-specification result to informal and formal laboratory and batch investigations.

After attending this audio event, you will know the FDA’s requirements for handling OOS results, phase I and II lab and full-scale investigations, Out Of Trend (OOT) investigations, and common pitfalls during OOS investigations.

Session Highlights

Here is a taste of what you will uncover:

  • FDA requirements for handling OOS and OOT results
  • Phase I: Laboratory Phase of Investigations
  • Phase II: Full Scale Investigation
  • Concluding an Investigation
  • Out Of Trend Investigations
  • Common Pitfalls During OOS Investigations
  • A review of recent OOS-related citations and warning letters

Who Should Attend

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

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

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 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...   More Info
More Events By The Speaker

Creighton University Health Sciences Continuing Education designates this activity for contact hour(s) for nurses. Nurses should claim only the credit commensurate with the extent of their participation in the activity.
Nurses licensed in Iowa and California: This activity was planned and developed in accordance with the continuing education standards of the American Nurses Credentialing Center (ANCC). The Iowa Board of Nursing and the California Board of Nursing will honor ANCC continuing education credits for face-to-face programs held outside Iowa and California, or for ANCC-approved online recorded courses taken in a self-study format.
In support of improving patient care, this activity has been planned and implemented by Creighton University Health Sciences Continuing Education and Audio Educator. Creighton University Health Sciences Continuing Education (HSCE) is jointly accredited by the Accreditation Council for Continuing Medical Education ( ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
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Audio Educator


Dear Valued Customers


We regret to announce that ProEdTech LLC and all its affiliate brands will cease operations on April 1, 2019.


We are no longer able to fulfill online orders. We will fullfill all DVD and book orders already placed.


Customers of canceled webinars and subscription products may request a refund at (800) 223-8720 or You must do so by April 1, 2019.


Thank you for your business and loyalty over the years. We sincerely apologize for any inconvenience caused.


Best regards,

The ProEdTech Team