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.
Maximizing Productivity with ChatGPT: AI Solutions for HR, …
Excel - Pivot Tables - The Key To Modern Data Analysis and …
New EEOC Report: Workplace Harassment Prevention Not Workin…
Human Error Reduction Techniques for Floor Supervisors
21 CFR Part 11 - Compliance for Electronic Records and Sign…
Form W-9 Compliance to Avoid Penalties: TIN Verification, B…
Transforming Change and Conflict into Diverse-Inclusive-Col…
Re-imagine Finance & Accounting Made Simple. Three Webinars…
Navigating 2025 Employment Laws: What Every Employer Needs …
Managing Difficult Employee Conversations
ChatGPT and Project Management: Leveraging AI for Project M…
Future Of Forecasting And Budgeting With Rolling Forecast
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
Internal Controls in Accounts Payable
The FMLA - An Employer's Guide to Compliance and Employee A…
Excel Power Skills: Master Functions, Formulas, and Macros …
Develop People Intelligence: Is Your Communication Style as…
The Impact of Artificial Intelligence on Your Workforce
AI in Everyday Work – help with Microsoft products
How to Document Employee Discussions and Why it is Important
Construction Lending And Real Credit Administration: Evalua…
The Anti-Kickback Statute: Enforcement and Recent Updates
Navigating FDA Inspections: From SOP to 483
2025 EEOC & Employers: Investigating Claims of Harassment …
2-Hour Virtual Seminar on DeepSeek R1 for Business and Mark…
Risk Analysis in the Medical Device Design Process
Introduction to Microsoft Power BI Dashboards
How To Get Control of Your Day, Life & Career - Time Manage…
AI Across the Business: Practical Use Cases for Founders an…
6-Hour Virtual Seminar on Learning the Highlights of Excel …
Female to Female Hostility @Workplace: All you Need to Know
Writing Effective 483 and Warning Letter Responses
FDA Recommendations for Artificial Intelligence/Machine Lea…
Language is Code - Intro to AI - Generative AI - ChatGPT an…
Understanding EBITDA – Definition, Formula & Calculation