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      Validation, Verification and Transfer of Analytical Methods in Amsterdam

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      June 15, 2020

      Monday   8:30 AM - 4:30 PM (daily for 2 times)

      Amsterdam, Netherlands

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      Validation, Verification and Transfer of Analytical Methods

      Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)
      About this Event


      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 2-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 procedures
      Learn how to plan, execute and document development and validation of methods developed in-house
      Be able to explain the different requirements for validation, verification and transfer of analytical procedures
      Understand the principles of validating methods developed in-house, verification of compendial methods, transfer of analytical procedures and demonstrating equivalency to compendial methods
      Be able to explain your company’s strategy for method validation, verification, transfer and equivalency testing
      Be able to select test parameters, test conditions and acceptance criteria for different analytical tasks
      Be able to justify and document decisions about revalidation after method changes
      Be able to define and demonstrate FDA and EU compliance to auditors and inspectors
      Be able to develop inspection ready documentation during on-going routine operation
      Understand statistical evaluation of validation test results
      Understanding what questions will be asked during audits and inspections and how to answer them

      Who will Benefit:

      QA managers and personnel
      Quality control
      Method development
      Analytical chemists
      Validation specialists
      Laboratory managers and supervisors
      Regulatory affairs
      Training departments
      Documentation departments

      DAY 01(8:30 AM - 4:30 PM)

      8:30-8:59 Registration Meet & Greet.

      9:00 AM Session Start

      Day 1 – Lectures and Workshop Exercises

      Lecture 1: Regulatory Background and Requirements

      FDA, EMA and international requirements (ICH Q2)

      Method validation terminology

      Compendial guidance on method validation, verification and transfer:

      USP General Chapters 1033, 1092, 1210, 1224, 1225, 1226 and 1467

      Ph. Eur. 5.21 – Chemometric Methods applied to Analytical Data

      EU GMPs: Chapter 6 and Annex 15

      Recent FDA and WHO method validation guidelines

      Different requirements for GLP, GCP and GMP

      Recent FDA and EMA enforcement action regarding method validation

      Introduction to quality risk management (ICH Q9)

      Exercise: evaluating risk in method validation, verification and transfer

      Lecture 2: Preparing for Method Validation

      Analytical Instrument qualification (USP <1058>)

      Computerized data systems (21 CFR 11, EU GMPs Annex 11 and GAMP 5)

      Validation of chromatographic data systems

      Validation and control of Excel spreadsheets

      Qualification of reference standards and materials

      Evaluating method performance prior to validation

      Lecture 3: Validation of Analytical Methods

      Developing a validation plan and SOP

      Phase-appropriate method validation

      Experimental approaches to method validation: accuracy, precision, intermediate precision, specificity, LOD, LOQ, linearity, range and robustness

      Demonstrating specificity: stress studies and impurity standards

      Dealing with validation failures

      Exercise: example validation report

      Lecture 4: Verification of Compendial Methods

      Scope, objectives and requirements of USP <1226>

      Changes allowed to chromatographic methods: USP <621> and Ph. Eur. 2.2.46

      Risk-based approach to method verification - which validation parameters should be verified?

      Method verification acceptance criteria

      Exercise: planning a method verification exercise

      DAY 02(8:30 AM - 4:30 PM)

      Day 2 – Lectures and Workshop Exercises

      Lecture 5: Transfer of Analytical Methods and Procedures

      Method transfer objectives

      Method transfer approaches

      Risks in method transfer

      Writing an effective transfer protocol

      Preparing the receiving laboratory for method transfer

      Method transfer to new technology: HPLC to UHPLC

      The method transfer report

      Exercise: planning a method transfer exercise using comparative testing

      Lecture 6: Demonstrating Equivalence to Compendial Methods

      Method validation vs. equivalence testing

      Definition, objective and scope of alternative methods

      Justification for the use of alternative methods

      FDA and USP requirements

      Equivalence testing - what and how much?

      Documentation requirements

      Lecture 7: Maintaining the Validated State (Lifecycle Management)

      Monitoring method performance: system suitability testing and quality control samples

      Change control for analytical methods

      Handling method changes pre- and post-approval

      Revalidation of analytical methods: when, and what to test

      Method review

      Continuous improvement

      Lecture 8: Recent Developments

      Lifecycle approach to analytical methods

      Method development and validation using Quality by Design principles

      Validation of bioanalytical methods according to the FDA and EMA guidelines

      Measurement uncertainty


      Mark Powell

      Director, Mark Powell Scientific Limited

      Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016, when his term of office ended. Between 2003 and 2013, he was the Analytical Development Manager, and later Scientific Manager, of a UK-based contract research organization which specialized in early-stage oral drug development. During this time, he was responsible for method validation, verification and transfer activities, as well as the qualification of laboratory instruments and computerized data systems. In 2013, he set up Mark Powell Scientific Limited, which provides training and consultancy services to pharmaceutical companies. Mark has since enjoyed working with companies of all sizes around the world on a variety of training and consultancy assignments, and has recently co-authored a White Paper on Pharmaceutical Data Integrity for the laboratory supply company VWR.

      Cost: $1,799

      Categories: Conferences & Tradeshows

      This event repeats daily for 2 times:

      Event details may change at any time, always check with the event organizer when planning to attend this event or purchase tickets.

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