Event Date/Time: Feb 26, 2009 End Date/Time: Feb 26, 2009
Registration Date: Feb 25, 2009
Early Registration Date: Feb 13, 2009
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Description

The lack of suitable analytical method validation is at the top of the list for cited FDA-483 observations in pharmaceutical and biotechnology companies. Method validation efforts lack the documented evidence to support product quality.



The analytical method validation process is a documented activity demonstrating that laboratory methods used during the analysis of raw materials, in-process and finished products are suitable for their intended use. The process encompasses a planned and systematic execution/collection of validation data supporting the analytical procedure.



The concept of analytical method validation needs to be integrated with instrument qualifications and software validation, as well as FDA/ICH and U.S. Pharmacopeia (USP) requirements for validation and verification criteria.



This live and comprehensive web seminar will address the analytical method validation from an FDA perspective, focusing on qualification parameters and performance criteria that will prevent objectionable findings during a regulatory audit, when properly implemented.



Learning Benefits:



Understanding the concept of analytical method validation
Identifying CFR sections corresponding to method validation
Identifying validation parameters and performance criteria
Learning what to expect from the FDA auditor during the evaluation of analytical methods
Learning FDA, ICH and USP requirements in method validation
Understanding the difference between method validation and verification
Understanding instrument and software qualification requirements
Defining stability testing, method transfer and revalidation criteria
Evaluation and trending of quality events related to analytical method validation

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