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Event Details


Out-of-Specifications (OOS)/Out-of-Trend (OOT) Investigations for Analytical Testing

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Who should attend?

This course will benefit analytical chemists, staff scientists, investigators in quality control lab, R&D, production, manufacturing, contract labs, quality assurance, regulatory affairs, laboratory auditors, lab inspectors, data reviewers, lab investigators. This course is not intended for microbiologists.


Deficiencies of Out-of-Spec (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 investigations.  Lack of consistency around investigations and root-cause analysis processes will lead to error and expensive laboratory activities.  This session will discuss the Guidance for Industry on OOS investigation issued in October 2006 by the FDA.  As testing becomes critical to determine the cause of OOS results, investigation process will be discussed and procedure that will minimize OOS.  It will also discuss the documentation system as well as CAPA activities.

This is a one and a half days interactive presentation, case studies, exercises and workshop on:

Determine failing analytical results

  • Determine regulatory impact of OOS
  • Review of warning letters relating to OOS/OOT
  • Definition of OOS
  • Outline a general OOS procedure

Investigation Process for OOS/OOT

  • Identifying and assessing OOS test results
  • Distinguish out-of-spec and out-of-trend investigations
  • Phase I:  Laboratory Investigation
  • Phase II:  Full Scale OOS Investigation

Discussing case studies for OOS investigation

  • Determine course of actions to process
  • Understand cross-functional investigation
  • Discuss investigation process and critical actions
  • How to prevent OOS investigations.

Workshop on:

Develop an investigation plan for different types of data

  • Design a systematic investigation plan
  • Investigate based on different types of analytical data
  • Determine root causes and acceptance criteria
  • Understand different components of an investigation report

Establish trends and Corrective Actions and Preventive Actions (CAPA)

  • Determine Critical Quality Attributes (CQA) to monitor quality
  • Establish trends using control charts
  • Determine quality markers for release and stability
  • How to minimize OOS/OOT investigation

Interactive discussions on trending and OOT investigation


Early Bird: Till July 8, 2018 $688 CAD + HST Regular Price: July 9, 2018 to August 23, 2018 $788 CAD + HST Academia / Government $498 CAD + HST



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