Bioanalytical Methods Validation

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.

Key Questions related to Bioanalytical Method Validation are:

• What are FDA and international requirements?
• What exactly are the expectations of inspectors?
• At what stage of the drug development should the method being analyzed?
• What parameters should be validated?
• Which acceptance limits MUST be defined?
• How should we document raw and source data?
• For how long should we archive validation documentation?
• What information should be included in regulatory submissions?
• I want to transfer a method from development to routine lab, do we need to revalidate?
• We want to transfer to an other site, do we need to revalidate?
• How to document bioanalytical method validation for the FDA?
• We have slightly changed our method, should we revalidate?
• We use software for automated method validation, should it be Part 11 compliant?

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will present strategies and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

• FDA regulations and guidelines
• Learning from the Crystal City FDA/Industry conference report
• 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 results
• 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

And for easy and instant implementation:
download 10+ documents from special seminar website

• SOPs
  - Validation of Bioanalytical Methods
  - Transfer of Analytical Methods
  - Change versus Adjustment of Compendial Methods
  - Recording of GLP Raw Data (electronic and paper)
• Checklist: - Validation of Bioanalytical Methods
• Master Plan Template with Examples: Validation of Bioanalytical Methods
• Reference Articles (Links)
  - Workshop/conference Report - Quantitative Bioanalytical Methods Validation and
  Implementation: Best Practices for Chromatographic and Ligand Binding Assays
  - The History of Bioanalytical Method Validation and Regulation
  - Application of confidence intervals to bioanalytical method validation
  - Adjusting Conditions for a Routine Reversed-Phase HPLC Assay,
  Part II: Changing Separation Conditions (link)
• FDA presentation: Documentation of Bioanalytical Data and Reports: U.S. Food and Drug Administration Perspective, M. Skelly, FDA CDER
• Warning letters and/or Inspectional observations related to method validation
• FDA Guidance and Policy:
  - Bioanalytical Method Validation

Who should attend?

• 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