Bioanalytical Methods Validation 2013 is a webinar that covers topics such as:
- Learning from the Crystal City FDA/Industry conference report.
- Logistics of validation
- Phased approach for validation during drug development
- Preparation and use of reference standards and equipment
- Development of a master plan and SOP for validation
- Defining validation experiments
- Defining parameters and acceptance limits
- Considerations for Microbiological and Ligand-binding Assays
- Documenting and archiving raw and source data
- To revalidate or not after method changes
- Working with QC samples for quantitative results
- Using computers for automated method validation
- Transferring and using the method to routine
- Documentation for the FDA and other agencies
- FDA regulations and guidelines
Bioanalytical Methods Validation 2013 brings together:
- Managers and analysts in forensic and toxicological laboratories
- Managers and analysts in bioanalytical laboratories
- Validation specialists
- QA managers and personnel
- Documentation department
- Training departments
- Bioanalytical scientists
- Consultants
- Biotech R&D staff
- Pharmacokinetic specialists
- Regulatory staff
- Clinical research associates
- Biopharmaceutical Consultants
- Outsourcing Professionals
