Validation of Analytical Methods for FDA Compliance: Step-by-Step - Webinar By GlobalCompliancePanel 2012

Key Topics

• Examples of warning letters and how to avoid them
• FDA regulations and guidelines
• Developing an SOP for method validation
• USP Chapters and ICH Guides
• Prerequisites for method validation
• Development of a validation plan for success
• Defining test conditions and acceptance limits
• Defining the minimum number of validation experiments that satisfy ICH, FDA and USP
• To revalidate or not after method changes
• Verification of compendial methods according to USP [1226]
• Seven most common method validation pitfalls and how to avoid them
• Transferring a method to routine according to USP [1224]
• Documentation for the FDA and for other agencies
• Using software for automated method validation

Who should Attend

GLP/GCP/GMP auditors, Laboratory managers and supervisors, QA/QC managers and personnel, ISO 17025 auditors, Regulatory affairs, Analysts and other laboratory staff, Consultants and Training departments.