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Validation, Verification and Transfer of Analytical Methods from FDA/EMA, USP and ICH 2017

Start Date:
Wednesday, 25 October, 2017
End Date:
Thursday, 26 October, 2017 6:00pm
Dermatology, Gastroenterology, Pain Management, Hepatology, Endocrinology, Infectious Disease, Internal Medicine, Emergency Medicine

Course "Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. 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.Method validation recently got highest attention from regulatory agencies and industry task forces. For example, FDA and EMA released guidelines on method validation and transfer, and USP has proposed new approaches chapters for integrated validation, verification and transfer of analytical procedures, for equivalency testing and for statistical evaluation.This two-day workshop will give attendees the background to understand the requirements, and even more significantly, it will focus on strategies and provide tools to implement most critical requirements.

It will also provide templates and examples to develop inspection ready documentation. Interactive workshop exercises will be dispersed into and between the presentations. About 50% of the total time will be dedicated to practical sessions with real life examples. After the course a variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what attendees have learned in the course.

Learning Objectives: Learn about the regulatory background and requirements for validation of analytical methods and proceduresLearn how to plan, execute and document development and validation of methods developed in-houseBe able to explain the different requirements for validation, verification and transfer of analytical proceduresUnderstand the principles of validating methods developed in-house, verification of compendial methods, transfer of analytical procedures and demonstrating equivalency to compendial methodsBe able to explain your company's strategy for method validation, verification, transfer and equivalency testingBe able to select test parameters, test conditions and acceptance criteria for different analytical tasksBe able to justify and document decisions about revalidation after method changesBe able to define and demonstrate FDA and EU compliance to auditors and inspectorsBe able to develop inspection ready documentation during on-going routine operationUnderstand statistical evaluation of validation test resultsUnderstanding what questions will be asked during audits and inspections and how to answer them Who will benefit: QA Managers and PersonnelQuality ControlMethod DevelopmentAnalytical ChemistsValidation SpecialistsLaboratory Managers and SupervisorsRegulatory AffairsTraining DepartmentsDocumentation DepartmentsConsultants Agenda: Day 1 Schedule Lectures 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:Going through the new FDA Method Validation guidanceScope and enforcement of the guidanceRecommendations for integrated procedure lifecycleExpectations for quality risk assessment, Quality by Design (QbD), multivariate experiments, system suitability testing, statistics,Revalidation vs. periodic reviewPreparing the lab for GMP compliant validation studiesLecture 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 Schedule Lectures 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 method SpeakerDr.

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, SwitzerlandDate: October 25th & 26th, 2017 and Time: 9:00 AM to 6:00 PMVenue: M&ouml;venpick Hotel Zurich-Airport Walter Mittelholzerstrasse 8 | 8152 Glattbrugg, Z&uuml;rich, Switzerland Price: Register now and save $200. (Early Bird)Price: $1,695.00 (Seminar Fee for One Delegate)Until September 10, Early Bird Price: $1,695.00 From September 11 to October 24, Regular Price: $1,895.00Register for 5 attendees Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)* Register for 10 attendees Price: $9,322.00 $16,950.00 You Save: $7,628.00 (45%)*Sponsorship Program benefits for "Quality Assurance Auditing for FDA Regulated Industry" seminarAt this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO's of various designations.

Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry. As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory-related industries and become known among these elite executives and subject matter experts.

Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants. For More Information- Contact us today! NetZealous LLC DBA Toll free: +1-800-447-9407Phone: +1-510-584-9661 Website: Registration Link - Follow us on LinkedIn: us our Facebook page: us on Twitter: Normal 0 false false false EN-US X-NONE X-NONE /* Style Definitions */ table.MsoNormalTable{mso-style-name:"Table Normal";mso-tstyle-rowband-size:0;mso-tstyle-colband-size:0;mso-style-noshow:yes;mso-style-priority:99;mso-style-parent:"";mso-padding-alt:0in 5.4pt 0in 5.4pt;mso-para-margin-top:0in;mso-para-margin-right:0in;mso-para-margin-bottom:10.0pt;mso-para-margin-left:0in;line-height:115%;mso-pagination:widow-orphan;font-size:11.0pt;font-family:"Calibri","sans-serif";mso-ascii-font-family:Calibri;mso-ascii-theme-font:minor-latin;mso-hansi-font-family:Calibri;mso-hansi-theme-font:minor-latin;}


Mvenpick Hotel Zurich-Airport

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Conference organized by NetZealous DBA as GlobalCompliancePanel

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