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.
Female to Female Hostility @Workplace: All you Need to Know
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Leadership: Strategic Planning and Decision Making
4-Hour Virtual Seminar on Transformational Leadership - The…
Managing Toxic Employees: Strategies For Leaders To Effecti…
Copilot and HR: An Introduction for HR Professionals
Negotiating Skills For Professional Results - Winning Strat…
Workplace Investigations 101: How to Conduct your Investiga…
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA…
Managing Complex Projects - Project Management
Excel Power Skills: Master Functions, Formulas, and Macros …
Ultimate Persuasion Strategies! - Secret Influence Tools & …
Do's and Don'ts of Giving Effective Feedback for Performanc…
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Using High-Performance Coaching for Managers to Address Per…
Utilizing HR Metrics to Illustrate & Improve Human Resource…
Understanding Artificial Intelligence (AI) & using Chat GPT
Do's and Don'ts of Documenting Employee Behaviour, Performa…
The Importance of the first 5 seconds when presenting
Project Management for administrative professionals
Employee Handbooks: 2025 Critical Issues