Investigating OOS Test Results – FDA Guidance & Practical Approach to Avoid Audit Findings

Course Description

Included with Registration

• 📘 Presentation Slides
• 🎓 Certificate of Completion
• 🎤 Live Q&A with Expert
• ⭐ 2 RAPS Credits

Out-of-Specification (OOS) results are one of the most critical issues in pharmaceutical laboratories and a frequent cause of FDA observations and warning letters.

Regulatory guidance requires that every OOS result be thoroughly investigated, documented, and scientifically justified.

This training provides a practical, step-by-step approach to OOS investigations—helping you identify root causes, apply correct procedures, and avoid common mistakes that lead to compliance issues.

By attending this training, you will be able to:

·      Conduct compliant OOS investigations aligned with FDA expectations

·      Identify root causes using a structured and scientific approach

·      Understand when retesting and resampling are appropriate

·      Avoid common mistakes that lead to audit findings

·      Apply proper documentation and CAPA (Corrective and Preventive Actions)

·      Ensure data integrity and regulatory compliance

Why this training is important

·      FDA requires investigation of every OOS result

·      Weak investigations can lead to 483 observations and warning letters

·      Poor documentation and incorrect retesting practices are common compliance gaps 

Webinar Takeaway

• The requirements for laboratory OOS investigations. 
• Latest Regulatory expectations.
• The laboratory OOS investigation process.
• Laboratory investigation, Phase I.
• Laboratory investigation, Phase II.
• Retesting.
• Resampling.
• Communicating with Quality Assurance.

Learning Benefits:

• Understand the developing expectation for appropriate OOS investigations. 
• Understand of the expectation for the identification of the cause of the OOS results.
• Gain a clear insight of the laboratory OOS investigation process.
• Learn the terminology associated with laboratory OOS investigations.
• Learn about outlier testing.
• Understand how the OOS laboratory investigation process relates to the general expectation for deviation         investigation.

Regulations and Guidances that will be covered (FDA, EU, Canada, WHO, ICH, other):

• US - 21CFR211.160, 192
• ICH Q7; 11.1
• FDA Guidance for the Industry; Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical          Production

Who will Benefit?

This webinar will provide a great resource to Pharmaceutical, Biotechnology, Biologics, Drugs, Medical Device, In-vitro Diagnostics Industry personnel within the following functions:

• - Quality Control
• - Quality Assurance
• - Microbiologist
• - Chemist
• - Analysts
• - Manufacturing
• - Validation
• - Facilities
• - Materials
• - Engineering
• - Management