Laboratory Investigation Out-of-Specification Results

In this 90-minute training on laboratory Out-of-specification (OOS) investigations, you will learn what constitutes an OOS observation, what is the OOS investigation process described in the OOS guidance and steps to be taken in the laboratory in the event of an OOS observation.

Why Should You Attend:

Inadequate procedures for laboratory Out-of-specification (OOS) investigations remain high on the list of FDA observations. The FDA has issued a guidance on the topic. OOS procedures and investigations are still a topic of FDA Investigator review and findings. An out-of-specification laboratory observation triggers emotional and political actions that inhibit a productive investigation with a timely conclusion.

Areas Covered in the Seminar:

• Regulations and Guidances that will be covered.
• US.
  • 21CFR211.160
  • FDA Guidance to the Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production

  • Who Will Benefit:

    The following individuals or disciplines will benefit from attending this Webinar:
    • Quality Control Managers
    • Quality Control Supervisors
    • Quality Control Analysts
    • Quality Control Record Reviewers