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  • Conducting Effective Investigations of Out of Specification
    and Atypical Laboratory Results

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Tuesday - Jul 16, 2013 10:00 AM
  • End Time:
  • Tuesday - Jul 16, 2013 12:00 PM
  • Location:
  • Online
  • This training on pharmaceutical laboratory OOS investigations will explain how to recognize and address atypical or out of specification results, using approaches which have been recommended by regulatory authorities, performing appropriate investigations.

    Why Should You Attend:

    Upon completion of this course the attendee should:

    1. Be familiar with various terms associated with investigations of atypical or out of specification results, and how to document those investigations.
    2. Be familiar with the FDA Guidance for Industry on Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production and how to apply it in laboratory situations.
    3. Be able to create a Laboratory Investigation Checklist and effectively document an investigation, including rationale and results.
    3. Know the importance of Corrective and Preventative Action (CAPA) and be able to identify appropriate CAPAs.
    5. Understand practical strategies to utilize outcomes from investigations for continuous improvement and reduction of future OOS results.
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