Understand - Is validation a regulated activity? When to pull the trigger for validation? Is a stable label internal standard always the best choice? Importance of suitability testing. Value of including critical reagents testing and suppliers. The limits of an assay and where they come from.
Areas Covered in the Seminar:
- 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
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Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates.