FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control

FDA's guidance on investigating out-of-specification (OOS) test results calls for failure investigations, and notes that much of it can also help when examining out-of-trend (OOT) results. This 90-minute webinar explains FDA requirements and guidelines for handling out-of-trend results in the pharmaceutical laboratory.

You'll review the relevant FDA regulations and the final Guidance for Industry on investigating OOS results, how OOS and OOT results differ, and how to write SOPs for OOT situations and laboratory failures. The session covers what to investigate and how, retesting, and evaluating results with historical data, QC samples and product control charts.

It also explains how to find the root cause, develop CAPA plans, prevent OOS results before they happen, and document OOS, OOT, investigations, root causes and CAPA in an FDA-compliant way.

• Explain FDA requirements and guidance that apply to OOT results
• Distinguish OOS from OOT results
• Write SOPs for OOT situations and laboratory failures
• Investigate and retest OOT results using historical data and control charts
• Find root causes and develop CAPA plans
• Document OOS, OOT, investigations and CAPA to FDA expectations

• FDA regulations and guidelines
• FDA's final Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
• The difference between OOS and OOT results
• Developing SOPs for OOT situations and laboratory failures
• Investigating OOT results: what and how
• Retesting OOT results
• Using historical data for OOT evaluation
• Using QC samples and product control charts
• Developing corrective and preventive action plans
• Finding the root cause of OOT results
• Strategies to prevent OOS situations before they occur
• FDA-compliant documentation of OOS, OOT, failure investigations, root causes and CAPA

Most companies have procedures for OOS results but not for OOT situations, and many are unsure how to interpret and apply FDA's guidance to them. Managing OOT results well also helps you avoid time-consuming OOS investigations later.

This session suits lab supervisors and managers, QA managers and staff, pharmaceutical R&D and documentation personnel, consultants, contract laboratories and CROs.

• Lab Supervisors and Managers
• QA managers and personnel
• Pharmaceutical R&D personnel
• Documentation
• Consultants
• Contract laboratories
• CROs

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.