Managing Failure Investigations and OOS Situations - Regulatory Requirements and Strategies for Implementation
Instructor:
Dr. Ludwig Huber
Product ID: 700107
Training Level: Advanced
- Duration: 60 Min
Why Should You Attend:
No or inadequate procedures for handling out of specification (OOS) situations and failure investigations are amongst the most frequently found deviations in FDA warning letters. No or inadequate procedures for handling out of specification (OOS) situations and failure investigations are amongst the most frequently found deviations in FDA warning letters.
Most companies have procedures but either they are not adequate or are not followed. This seminar will guide attendees through the entire process from detection an out-of-specification result to informal and formal laboratory and batch investigations.
What Attendees will Learn:
- What do FDA and other regulations say about Failure Investigations and OOS
- What exactly are the expectations of inspectors
- How to develop an efficient and compliant procedure for failure investigations?
- When and what to retest?
- How to manage batch investigations
- How can I avoid OOS situations BEFORE they occur
- How should I document failure investigations and OOS?
- How to develop a corrective and preventive action plan
Who Will Benefit:
- QA managers and personnel
- Analysts and lab managers
- CAPA management
- Regulatory affairs
- Human resources (HR) managers and staff
- Training departments
- Documentation department
- Consultants
Ludwig Huber,, Ph.D., is Compliance Program Manager at Agilent Technologies. He is the editor of www.labcompliance.com, the global on-line resources for validation and compliance issues for laboratories. He is the author of the books "Computer System Validation", "Network Quality Package" , and "Validation of Computerized Analytical and Networked Systems".For more information, visit Dr. Huber’s website: www.ludwig-huber.com
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