Validation of Analytical Methods for FDA Compliance: Step-by-Step - Webinar By GlobalCompliancePanel
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Category online training,Validation of Analytical Methods,FDA Compliance,USP Chapters,ICH Guides,FDA regulations, SOP for method validation
Deadline: May 24, 2012 | Date: May 24, 2012
Venue/Country: Online Training, U.S.A
Updated: 2012-04-09 20:27:07 (GMT+9)
Call For Papers - CFP
Overview: Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented. This webinar will provide a good understanding on how to effectively prepare, conducts and document method validation experiments for FDA and ISO 17025 compliance.Reference material for easy implementation:SOP: Validation of Analytical MethodsChecklist: Validation of Analytical Methods65-page Primer: Validation of Analytical MethodsAreas Covered in the Session:FDA regulations and guidelinesExamples of warning letters and how to avoid themUSP Chapters and ICH GuidesDeveloping an SOP for method validationDevelopment of a validation plan for successPrerequisites for method validationDefining the minimum number of validation experiments that satisfy ICH, FDA and USPDefining test conditions and acceptance limitsVerification of compendial methods according to USP <1226>To revalidate or not after method changesTransferring a method to routine according to USP <1224>Seven most common method validation pitfalls and how to avoid themUsing software for automated method validationDocumentation for the FDA and for other agenciesWho Will Benefit:Laboratory managers and supervisorsGLP/GCP/GMP auditorsISO 17025 auditorsQA/QC managers and personnel Analysts and other laboratory staff Regulatory affairs Training departments ConsultantsPrice List:Live : $245.00Corporate live : $995.00Recorded : $295.00webinars
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