Validation of Bioanalytical Methods and Procedures for FDA Compliance

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Webinar Duration: 75 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Ludwig Huber

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 analyte. 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.

Reference material for easy implementation:
SOPs: Validation of Bioanalytical Methods
Checklist: - Validation of Bioanalytical Methods
Master Plan Template with Examples: Validation of Bioanalytical Methods
FDA Guidance and Policy: Bioanalytical Method Validation
New EMA Guideline on Bioanalytical Methods Validation

Areas Covered in the Session:
- 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:
- Laboratory managers and supervisors
- GLP/GCP/GMP auditors
- QA/QC managers and personnel
- Analysts and other laboratory staff
- Regulatory affairs
- Training departments
- Consultants

Ludwig Huber Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. For more information, please visit Dr. Huber’s website

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