Out-of-Specification (OOS) and Out-of-Trend (OOT) Investigation Principles Training
Investigation workflow for lab results.
4 000 Skr
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Purpose:
Provides structured training content on the principles and expectations for the investigation of out-of-specification (OOS) and out-of-trend (OOT) results to support consistent and compliant quality decision-making.
Regulatory Alignment:
Aligned with EU GMP requirements for laboratory controls and investigation management, and consistent with ICH Q10 (Pharmaceutical Quality System) expectations.
Included Files:
• OOS and OOT investigation training material
• Overview of investigation phases and documentation expectations
• Illustrative examples and discussion points for GMP laboratories
Format:
Microsoft PowerPoint or Microsoft Word (fully editable)
Intended Users:
Pharmaceutical manufacturers, quality control laboratories, quality assurance teams, and technical personnel involved in GMP investigation activities.