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Managing Out of Trend Results in Pharmaceutical Manufacturing and Quality Control
In this training you will learn difference between Out-of-Specification (OOS) and Out-of-trend (OOT), requirements for OOT and how to manage OOT results for FDA compliance.
Areas Covered in the Seminar:
- Understand FDA regulations and guidelines.
- FDA's final OOS Guidance for Industry: Requirements for OOT.
- Difference between OOS and OOT result.
- 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.
- Examples: Going different types of case studies.
Hand-outs:For easy implementation, attendees will receive
- SOP: Handling OOT results
- SOP: Out-of-Specification Data Trending
- Checklist: Handling OOT Situations
Who Will Benifit:
- Pharmaceutical industry
- Contract Laboratories
- Laboratory managers and supervisors
- GMP auditors
- QA/QC managers and personnel
- Qualified persons (for EU compliance)
- Analysts and other laboratory staff Regulatory affairs
Ludwig Huber Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at 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. For more information, visit Dr. Huber’s website: www.ludwig-huber.com .
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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