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FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control
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.
Why Should You Attend:
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.
For easy implementation, attendees will receive
- Handling OOT results
- Handling OOS results
- Out-of-Specification Data Trending
- Checklist: Handling OOT Situations
Areas Covered in this Webinar:
- FDA regulations and guidelines.
- FDA's final Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.
- Difference between OOS and OOT results.
- Developing SOPs for OOT situations and laboratory failures.
- Investigating OOT results: what and how.
- Retesting of OOT results.
- Using historical data for OOT evaluation.
- Using QC samples and product control charts for evaluation.
- Developing corrective and preventive action plans.
- Finding the root cause for OOT results.
- Strategies to avoid OOS situations BEFORE they occur.
- FDA compliant documentation of OOS, OOT, failure investigations, root causes and CAPA.
Who Will Benefit:
- Lab Supervisors and Managers
- QA managers and personnel
- Pharmaceutical R&D personnel
- Contract laboratories
Dr. Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance for Agilent Technologies. He is the editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare.
ComplianceOnline would process/provide refund only if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs."
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Dr. Ludwig Huber
Understanding and Implementing USP <1058>: Analytical Instrument Qualification Change Control for Computer Systems - strategies and tools for FDA compliance Master Planning for Computer System Validation Managing Failure Investigations and OOS Situations - Regulatory Requirements and Strategies for Implementation