This webinar will discuss the FDA requirements and guidelines for investigating Out-of-trend (OOT) results in the pharmaceutical laboratory. It will also cover FDA-compliant documentation of OOT, failure investigations, root causes, and CAPA.
FDA's guidance on OOS test results requires failure investigations and other steps for Out-of-Specification (OOS) and Out-of-trend (OOT) results. While most companies are familiar with and have procedures for OOS results, this is not the case for OOT situations. The guide states: "Although the subject of this document is OOS results, much of the guidance may be useful for examining results that are out of trend". Managing OOT results also helps to avoid time-consuming OOS results. The industry is unsure how to interpret and implement the FDA guidance.
This session will equip you with the knowledge and comprehensive understanding of FDA requirements for Out-of-Trend Results in pharmaceutical quality control.
FDA's guidance on OOS test results requires failure investigations and other steps for Out-of-Specification (OOS) and Out-of-trend (OOT) results. While most companies are familiar with and have procedures for OOS results, this is not the case for OOT situations. The guide states: "Although the subject of this document is OOS results, much of the guidance may be useful for examining results that are out of trend". Managing OOT results also helps to avoid time-consuming OOS results. The industry is unsure how to interpret and implement the FDA guidance.
This session will equip you with the knowledge and comprehensive understanding of FDA requirements for Out-of-Trend Results in pharmaceutical quality control.
Kelly Thomas
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.
FMLA Compliance in 2025: A Comprehensive Guide & Strategies…
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
2025 EEOC & Employers: Investigating Claims of Harassment …
How to Manage the Legal Landmine of the FMLA, ADA and Worke…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Enhance Your Confidence and Leadership Presence
Managing Toxic & Other Employees Who Have Attitude Issues
Stress, Change And Team Resilience Through Humor: An Intera…
The Importance of the first 5 seconds when presenting
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
Excel Power Skills: Master Functions, Formulas, and Macros …
Female to Female Hostility @Workplace: All you Need to Know
Cleaning Data without Complex Functions - A Course for Data…
The Monte Carlo Simulations in Excel for Risky Investments
How to Give Corrective Feedback: The C.A.R.E. Model - Elimi…
6-Hour Virtual Seminar on Learning the Highlights of Excel …
Interactive dashboards & analytics in Excel