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.
Understanding the Artificial Intelligence Landscape
Holiday Stress and Loss: The Art of Stress Resilience in E…
Establishing Appropriate Quality Metrics and Key Performanc…
OSHA Requirements for Supervisors, Project Leaders & HR - W…
Is Your Culture Working For or Against Your Success? If You…
Excel - 10 Key Worksheet Functions to Skyrocket Your Produc…
Using High-Performance Coaching for Managers to Address Per…
Ultimate Persuasion Strategies! - Secret Influence Tools & …
Utilizing HR Metrics to Illustrate & Improve Human Resource…
Red flags that can render your OSHA Safety Program Complete…
Transform Data into Insights: A Beginners Guide to Excel Pi…
The Human Element of Leadership in the Hybrid Work Experien…
What If Analysis Tools in Excel: Goal Seek, Solver, and Dat…
How to Navigate Political Speech in the Workplace
Project Management for administrative professionals
3-Hour Virtual Seminar on Chat GPT for Project Management i…
Mastering Year-End Payroll and Tax Compliance for 2024
Eliminate Harmful And Unproductive Drama In The Workplace
How to Prepare For and Host a FDA Inspection and Respond to…
Excel - Pivot Tables - The Key To Modern Data Analysis and …
The Anti-Kickback Statute: Enforcement and Recent Updates
FDA Technology Modernization Action Plan (TMAP) and Impact …
5 Key Components of Good Manufacturing Practices to obtain …
Team Synergy: How to Harness Collective Intelligence to Max…
Successful Strategies for FDA Expedited Pathways for Your D…
The Power Of Trust In The Workplace- Improving Your Career …
Managing Toxic & Other Employees Who Have Attitude Issues
Protect Your Company With The End of the Year HR Checklist
Do's and Don'ts of Giving Effective Feedback for Performanc…
So, You’re Now the “Boss”: Essential Skills to Succeed as a…
Onboarding is NOT Orientation - How to Improve the New Empl…
Construction Lending And Real Credit Administration: Evalua…
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA…
Improving Employee Engagement & Retention Through Stay Inte…
Building GMP Excellence: A Guide to Implementing Compliant …
4-Hour Virtual Seminar on Transformational Leadership - The…
Understanding cognitive load in medical device design
Human Error Reduction Techniques for Floor Supervisors
Excel Power Skills: Master Functions, Formulas, and Macros …
