Validation of Bioanalytical Methods and Procedures for FDA Compliance
Instructor:
Dr. Ludwig Huber
Product ID: 702229
- Duration: 75 Min
Why Should You Attend:
Analyzing biological fluids is one on the most difficult tasks in analytical laboratories. Most challenging are interferences from matrices and decomposition products combined with low concentrations of analytes. Correct validation of bioanalytical methods according to recent FDA and industry recommendations ensures reliability, consistency and accuracy of bioanalytical data. But because of the difficult nature of the analysis there are many questions.. This seminar will demonstrate how to validate bioanalytical methods and procedures for FDA compliance.
Learning Objectives:
- FDA regulations and guidelines.
- Understanding the FDA and EMA Guidances for Bioanalytical Method Validation.
- Phased approach for validation during drug development.
- Logistics of validation.
- Development of a master plan and SOP for validation.
- Preparation and use of reference standards and equipment.
- Defining parameters and acceptance limits.
- Defining validation experiments.
- Documenting and archiving raw and source data.
- Considerations for Microbiological and Ligand-binding Assays.
- Working with QC samples for quantitative routine analysis.
- To revalidate or not after method changes.
- Transferring and using the method to routine.
- Using computers for automated method validation.
- Documentation for the FDA and other agencies.
Who will Benefit:
- Managers and analysts in bioanalytical laboratories
- Managers and analysts in forensic and toxicological laboratories
- QA managers and personnel
- Validation specialists
- Training departments
- Documentation department
- Consultants
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. For more information, visit Dr. Huber's website: www.ludwig-huber.com
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