Inadequate investigation of out-of-specification (OOS) results in the laboratory is a common observation cited in FDA 483s and Warning Letters. Regulatory investigators worldwide are closely scrutinizing laboratory operations, and FDA includes OOS investigations as a quality metric. Failure to investigate OOS results appropriately can constitute a data integrity issue—for example, retesting without justification, cherry-picking data, or “experimental” testing prior to GMP release testing. Establishing a clear, defined strategy before encountering an OOS is critical for compliance.

This live webinar will provide a detailed understanding of how a compliant laboratory manages testing and OOS investigations, and how laboratories interact with other functional units during the process. It will outline FDA guidance on handling OOS results and provide a clear process for compliant laboratory operations. Real-world examples from Chemistry and Microbiology in QC and manufacturing testing will also be discussed.

This Live Webinar Will Cover

• Setting up a compliant laboratory
• Requirements for laboratory OOS investigations
• Latest regulatory expectations
• Laboratory OOS investigation process
• Phase I investigations
• Phase II investigations
• Retesting and resampling
• Communicating with QA and other departments

Learning Benefits

• Understand what a compliant laboratory looks like
• Recognize regulatory expectations for OOS investigations
• Learn the expectation for root cause identification in OOS results
• Gain a clear understanding of the OOS investigation process
• Learn key terminology associated with OOS investigations
• Understand outlier testing
• See how OOS investigations align with deviation investigation expectations

Regulations and Guidances Covered

• US – 21 CFR 211.160, 192
• ICH Q7; 11.1
• FDA Guidance for Industry: Investigating OOS Test Results for Pharmaceutical Production

Who Should Attend

• Senior Management
• Quality Assurance
• Quality Control Operations
• Regulatory Affairs
• Regulatory Compliance
• QA Product Reviewers
• Production Management