Bioanalytical Methods Validation - Webinar By ComplianceOnline

In this Bioanalytical methods validation understand the Clear, Consistent and compliant approaches for instrumental, ligand binding, and cell based methods.
ComplianceOnline 2011
ComplianceOnline 2011
Aug. 23, 2011 - PRLog -- his webinar will discuss the best practices of Bioanalytical method validation, including components of a validation, how to include critical reagents comparison, selectivity experiments, assessment of stability. Concept of plate and experiment separation. Importance of communication between the development and the validation labs, accuracy of transfer documents (SOPs). Predicate rules, support of clinical and non clinical sample analysis.

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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Tags:Bioanalytical Methods Validation, Regulatory Compliance Training, Corporate Compliance Training
Industry:Education, Manufacturing
Location:Palo Alto - California - United States
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