Validation of Analytical Methods and Procedures - Design, Conduct and Document for Efficiency and Compliance
Instructor:
Dr. Ludwig Huber
Product ID: 700158
Training Level: Advanced
- Duration: 60 Min
Why Should You Attend:
Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented. This seminar will guide attendees through the entire process from defining specifications, through developing and implementing validation experiments to FDA compliant documentation.
What Attendees will Learn:
- FDA regulations and guidelines
- Developing an SOP for method validation
- Development of a validation plan
- Defining parameters and acceptance limits
- Validation of standard/compendial methods
- Change control and revalidation
- Transferring a method to routine or other sites
- Using software for automated method validation
- Documentation for the FDA and other agencies
Who Will Benefit:
Everybody involved in the validation of analytical methods.
- Analysts and lab managers
- QA managers and personnel
- Validation specialists
- Regulatory affairs
- 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
More Training By Experts
- 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
- Effective Training for FDA Compliance: What to train - How much to Train - How to Document Effectiveness
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