Conference Description:
This Method Validation training in drug development process will provide guidance in setting appropriate specifications, determining if the assay is validatable, and monitoring progress during the validation.
Why Should You Attend:
This webinar will address frequently observed issues and problems with method validations. Validated methods are required for Phase III of the drug development process. Moving methods from the development phase to the validated phase ready for sample analysis does not always occur without unforeseen issues arising. Differences in laboratories and analysts, as well as instrumentation can contribute to delays in validating methods.
Setting appropriate specifications and criteria based on solid data from development and qualification will contribute to successful completion of method validations. Key issues may be overlooked or not anticipated when methods are developed, optimized, and qualified that can lead to assay failures during validation. Rushing to judgment can lead to unnecessary delays and repeated work. Setting solid requirements for determining that methods are ready for validation is critical. Unambiguous documentation of the method is also key when new analysts or laboratories are included in cross-validations. The attendees will understand key concepts from practical examples that will address major issues encountered during method validation.
Start Date: 2012-03-07
Last Day: 2012-03-07
Contact Person: Referral
Email: referral@complianceonline.com
Address:
2600 E. Bayshore Road, Palo Alto, California, 94303, United States
Tel: +1-650-620-3915
Fax: +1-650-963-2556
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