Validating Immunoassays Using the Fluorescence Polarization Assay for the Diagnosis of Brucellosis David Gall and Klaus NielsenStep-by-Step Analytical Methods Validation and Protocol in the Quality System Compliance Industry Ghulam A. ShabirGood Analytical Method Validation Practice: Setting Up for Compliance and Efficiency: Part I Stephan O. Krause, Ph.D.Good Analytical Method Validation Practice: Deriving Acceptance Criteria for the AMV Protocol: Part II Stephan O. Krause, Ph.D.

Biological Method Validation A Practical Approach Cindy GreenDefining a Master Plan for the Validation of Analytical Methods Paul A. Winslow, Ph.D. and Richard F. Meyer, Ph.D.FDA and Industry Address Analytical Validation Issues for the Pharmaceutical Industry Jerry Lanese, Ph.D.Guidance for Industry Bioanalytical Methods Validation for Human Studies US Food and Drug Adminstration

Method Validation Studies: How GLP Interacts with Guidance Documents Steven S. Kuwahara, Ph.D.Reduction of Analytical Method Variability in an R&D Laboratory: A Case Study Briank K. Nunnally, Andre Johnson, and Raymond KaiseMethod Validation (for Medical Devices) Laure LarkinUse of Monte Carlo Simulation to Address CMC Issues Harry Yang, Ph.D.Validation of Dissolution Methods Gregory P. Martin and Vivian GrayUSP <1010> Analytical Data-Interpretaion and Treatment Appendix E: Compa

Table of ContentsFDA SIgnals a New Approach for Analytical Method Validation by Tim SandleAligning with the New Guidance: FDA Analytical Procedures and Method Validation by Ivan SotoLifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Validation by a USP Validation and Verification Expert Panel

-User Requirements and Implementations of a Risk-Based, Compliant Stability Management System that is Aligned with FDA's New Data Integrity Draft Guidance- Novel Approaches Involving Lean Stability Processes and Outsourcing- Risk-Based Processes to Enhance Stability Programmes- OOT and OOS in Stability Studies- Moisture and its Control in Stability- Theory and Practical Design of Forced Degradation StudiesPlus! Benefit from materials from 6 breakout sessions. Download the compendia.

Our compendia features new content, tailored directly from industry feedback, on the most pressing needs and successful solutions for method validation today. Featured conference highlights include:Practical Applications for Critical Method Validation ProceduresIndustry Pulse on Emerging Regulatory Trends and Waring Letters – FDA, MHRA, USP and BeyondValidation and Transfer of Analytical Methods for Biologics to Enable Commercial LaunchContinuous P

Analytical Methods for Biological Products by Lokesh Bhattacharyya, U.S. Food and Drug Administration (FDA)EU GMP Guide - Recent Challenges for the Quality Control Laboratory by Michael Zwitkovits, Austrian Federal Office for Safety in Health Care (AGES)Lessons Learned from FDA Warning Letters to Strengthen Your Programme and Mitigate Risk by Karen Ginsbury, PCI Pharma Ltd.Click here to download the agenda for Stability Testing. Click here to download the agenda for Analytical Procedures & Methods Validation.Download the conference compendium.