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Bioanalytical Methods Validation - Webinar By ComplianceOnline

Added by Referral on 2011-01-19

Conference Dates:

Start Date Start Date: 2011-08-02
Last Date Last Day: 2011-08-02

Conference Contact Info:

Contact Person Contact Person: Referral
Email Email:
Address Address: 2600 E. Bayshore Road, Online Event,Palo Alto, CA, 94303, United States
Phone Tel: 650-620-3915
Phone Fax: 650-963-2556

Conference Description:

In this Bioanalytical methods validation understand the Clear, Consistent and compliant approaches for instrumental, ligand binding, and cell based methods.

This 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
Transferring and using the method to routine
Using computers for automated method validation
Documentation for the FDA and other agencies
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