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Mar 12, 2009 - Mar 13, 2009 Renaissance Beijing Capital Hotel Beijing (munic.) China
•Understand the background and historical perspective of Good Laboratory Practice regulations in the US •Become fully aware of the format options for SOP documentation and writing •Learn about the FDA¡¯s GLP requirements during the product development process including associated process, analytical and facility validation •Enforce regulations and operation procedure in your own company and set up a quality system which meets FDA data requirements •Understand the auditing and inspection process as it applies to GLP compliance, including first party (internal), client and regulatory authority audits •Gain a thorough grounding on the validation of computerized systems and analystical equipment to comply with GLP regulations •Obtain a thorough overview of documentation of assay procedure and analytical method validation |