Event Detail
Validation of Analytical Methods for FDA Compliance: Step-by-Step - Webinar By GlobalCompliancePanel
May 24, 2012 - Online Training DE US
GlobalCompliancePanel
webinars@globalcompliancepanel.com
Phone: 8004479407
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 Methods Checklist: Validation of Analytical Methods 65-page Primer: Validation of Analytical Methods Areas Covered in the Session: FDA regulations and guidelines Examples of warning letters and how to avoid them USP Chapters and ICH Guides Developing an SOP for method validation Development of a validation plan for success Prerequisites for method validation Defining the minimum number of validation experiments that satisfy ICH, FDA and USP Defining test conditions and acceptance limits Verification of compendial methods according to USP <1226> To revalidate or not after method changes Transferring a method to routine according to USP <1224> Seven most common method validation pitfalls and how to avoid them Using software for automated method validation Documentation for the FDA and for other agencies Who Will Benefit: Laboratory managers and supervisors GLP/GCP/GMP auditors ISO 17025 auditors QA/QC managers and personnel Analysts and other laboratory staff Regulatory affairs Training departments Consultants Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Phone: 800-447-9407 Fax: 302-288-6884