This toolkit highlights the most comprehensive information on analytical method validation and method development. With over 150 pages from the Journal of Validation Technology and the Journal of GXP Compliance, two hours of pre-recorded webinars, and thousands of slides from IVT's annual method validation conference, these products will ensure you keep abreast of ongoing method strategies and global regulatory trends.
Products in this Toolkit
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
In this webinar, Sam Venugopal discusses the results of CRADA's FDA-sponsored study on identifying the bottlenecks for implementation of quality by design (Qbd) in manufacturing facilities and opportunities for improvement. Download "Understanding the Challenges Behind QbD – A Review of Leading Practices"
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: Comparison of Methods Lynn TorbeckAddressing Compliance Concerns During Dissolution Method Development, Validation,...
Understand the regulators' expectations for QbDMake the business case for a QbD programUnderstand what new / additional expertise will be needed to:Establish a design spaceDescribe a design space in the submission.
Download the compendium here. Points of discussion were:Evaluate and validate the robustness of an analytical methodDetermine lifecycle, phase appropriate activitiesOvercome challenges of limits of calculations Implement an effective method transfer strategyPerform an analytical methods comparability study
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 Launch