Course Catalog

Conducting Successful OOS/OOT Investigations for Analytical Testing

Deficiencies of OOS investigations continue to be the major cause of warning letters in the pharmaceutical industry. FDA requires that all out-of-specification results must be investigated; therefore, an effective and compliant quality management system requires well-documented, thorough investigations for OOS. Key challenges for many companies are having a clear understanding of regulatory expectations on how to handle OOS and OOT. Lack of consistency around investigation and root-cause analysis processes will lead to error and expensive laboratory activities. This session will discuss the Guidance for Industry on OOS/OOT investigation issued in October 2006 by the FDA. As testing become critical to determine the cause of OOS results, investigation process will be discussed and procedure that will minimize OOS and identify OOT. It will also discuss the documentation system as well as CAPA activities.

Course Details

Key Topics

  • Understanding Regulatory Expectations on OOS/OOT
  • OOS Investigation Process
  • Understanding OOT and Documentation

Information

Deficiencies of OOS investigations continue to be the major cause of warning letters in the pharmaceutical industry. FDA requires that all out-of-specification results must be investigated; therefore, an effective and compliant quality management system requires well-documented, thorough investigations for OOS. Key challenges for many companies are having a clear understanding of regulatory expectations on how to handle OOS and OOT. Lack of consistency around investigation and root-cause analysis processes will lead to error and expensive laboratory activities. This session will discuss the Guidance for Industry on OOS/OOT investigation issued in October 2006 by the FDA. As testing become critical to determine the cause of OOS results, investigation process will be discussed and procedure that will minimize OOS and identify OOT. It will also discuss the documentation system as well as CAPA activities.

Who Should Attend

This series will benefit analyst to group manager who are responsible for acquiring, evaluating or reporting analytical results. It is designed to provide key principles for OOS and OOT investigations.

Benefits

  • Understand regulatory expectations for OOS investigation
  • Define documentation system for reporting data
  • Build ruggedness into the analytical procedures to prevent OOS occurrences
  • Build compliance into the investigation process to minimize OOS
  • Define and monitor Corrective and Preventive Actions.

Agenda

  • Understanding Regulatory Expectations on OOS/OOT
    • Determine regulatory impact of OOS
    • Review of warning letters relating to OOS/OOT
    • Definition of OOS and OOT
    • Outline a general OOS procedure
  • OOS Investigation Process
    • Identifying and assessing OOS test results
    • Phase I: Laboratory Investigation
    • Phase II: Full Scale OOS Investigation
    • Conclusions and Documentations
  • Understanding OOT and Documentation
    • Recognize different types of OOT results
    • Determine course of actions to process
    • Understand cross-functional investigation
    • Establish documentation and performance metrics

Course Locations

Date

TBA

Check-in opens at 7:30 a.m. on the day of the course.

Course runs from 8:30 a.m. to 5:00 p.m.

Register Via Mail

Venue

TBA

The course fee includes a course binder and a continental breakfast each day.

Five for Four! Register five people for one course, one person for five courses, or any combination in between and your fifth registration is free. Note: This discount is only available if you register by fax or mail and mention this discount. May not be combined with any other offer.


Pricing
  Member Non-Member
Advanced $795 $995
Standard $1,095 $1,295

About the Instructor

  • Kim Huynh-Ba

    has almost 28 years of experience in GMPs, analytical development and stability sciences in Pharmaceutical Industry.