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Validation, Verification and Transfer of Analytical Methods 2017

Start Date:
Monday, 20 March, 2017
End Date:
Tuesday, 21 March, 2017 6:00pm
Gastroenterology, Infectious Disease, Rheumatology, Internal Medicine, Emergency Medicine, Hematology, Pulmonary Medicine, Physical Medicine

Overview:Analytical methods and procedures should be validated to ensure reliability, consistency and accuracy of analytical data. Compendial methods should be verified to demonstrate the suitability of laboratories to successfully run the method and when methods are transferred between laboratories successful transfer should be demonstrated through testing. In case a laboratory wants to use an alternative method instead of a compendial method, equivalency of the alternative method to the compendial method should be demonstrated.Who will benefit:QA Managers and PersonnelQuality ControlMethod DevelopmentAnalytical ChemistsValidation SpecialistsLaboratory Managers and SupervisorsRegulatory AffairsTraining DepartmentsDocumentation DepartmentsConsultantsAgenda:Day 1 ScheduleLectures and Workshop ExercisesLecture 1:Regulatory Background and RequirementsFDA and international requirementsThe importance of ICH Q2 and USP chaptersUSP approach for method validation: New/revised Chapters 220, 1200, 1210, 1220, 1225Learnings from the NEW FDA and WHO method validation guidelinesDifferent requirements for GLP, GCP and GMPThe importance and steps of risk assessmentExercise: Define risk numbers for different methodsLessons from recent FDA Warning LettersPlanning for cost-effective implementationLecture 2:Preparing Your Lab for Validation StudiesAnalytical Instrument qualificationPart 11/Annex 11 compliance of computer systemsValidation of chromatographic data systemsValidation and control of Excel spreadsheetsQualification of reference standards and materialsLecture 3:Validation of Analytical Methods and ProceduresDeveloping a validation plan and SOPICH Q2 validation and test parameters: Accuracy, precision, intermediate precision, specificity, LOD, LOQ, linearity, range, robustness, ruggednessExamples for application specific acceptance criteriaExamples for design and execution of test experimentsEvaluation of test results: using statistical modelsHandling deviations from expected test resultsGoing through an example validation reportLecture 4:Verification of Compendial MethodsFDA and equivalent international expectationsScope and objectives of USP <1226>USP <1226> verification requirementsRisk based approach for type and extent of verification testingWhich validation parameters should be verifiedLogical process to set acceptance criteriaExercise: Application based verification testingDay 2 ScheduleLectures and Workshop ExercisesLecture 1:Transfer of Analytical Methods and ProceduresThe main objective of formal method transferLearnings from EU GMP Chapter 6 on method transferUSP <1224> : Choosing the approach for transferApproach and benefits of comparative testing:Developing a risk based test planPlanning and developing an effective transfer protocolPreparing the receiving lab for the transferMethod transfer to new technology:: HPLC to UHPLCPreparing the method transfer reportExercise: Application specific comparative testingLecture 2:Demonstrating Equivalency to Compendial MethodsMethod validation vs. equivalency testingDefinition, objective and scope of alternative methodsJustification for the use of alternative methodsFDA and USP requirementsOptions for alternatives to approved proceduresExercise: Equivalency testing - what and how muchDocumentation requirementsLecture 3:Maintaining the Validated StateMonitoring method performance: system suitability testing and quality control samplesChange control procedure for analytical methodsHandling method changes vs. adjustmentsRevalidation of analytical methods: when, what to testMethod reviews as a cost effective alternative to time based revalidationGoing through a review processRegulatory reporting of post-approval changesExamples for continuous improvementsLecture 4:Special Applications and Validation ProcessesPreview to the expected new USP general chapter <1220> "The Analytical Procedure Lifecycle"Method development and validation using Quality by Design principles following the new FDA GuidanceValidation of bioanalytical methods according to the FDA and EMA guidelinesValidation of stability indication methodSpeaker: Dr.

Ludwig HuberChief Advisor - Global FDA compliance, Labcompliance Chairman, presenter and panel discussion member at US-FDA Industry Training sessions and conferencesServed as team member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP special interest group on Laboratory Systems.Presenter of the Year of the Institute for Validation and TechnologyDirector and chief editor of, the global on-line resource for validation and compliance issues for laboratories.

Author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems"Location: Zurich, Switzerland Date: March 20th & 21st, 2017 and Time: 9:00 AM to 6:00 PM Venue: Hilton Zurich Airport Address: Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50 Price: Price: $1,695.00 (Seminar Fee for One Delegate) Until February 10, Early Bird Price: $1,695.00 from February 11 to March 18, Regular Price: $1,895.00 Register for 5 attendees Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)* Quick Contact:NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407Fax: 302-288-6884Email:


Hilton Zurich Airport Hohenbuhlstrasse 10,
8152 Opfikon-Glattbrugg,
Switzerland. +41 44 828 50 50

Organizer Details

Conference organized by NetZealous DBA as GlobalCompliancePanel

NetZealous LLC-globalcompliancepanel, 161 Mission Falls Lane, Suite 216, Fremont,CA94539, USA
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