Analytical Method Development and Validation

    3-5 June 2024, live online training


    Regulatory guidance underpinning analytical method development and validation is changing.  Regulators are now emphasising a Quality by Design (QbD) approach to analytical methods that supports their suitability for use over their entire life cycle. New draft ICH guidances on method development and validation (ICH Q14 and ICH Q2 respectively) were published for consultation in March 2022. The purpose of this course is to set out these new guidances in the context of other compendial and regulatory agency expectations and to help attendees avoid common mistakes during the development and validation of test methods, whether for biological or chemical drugs. Key concepts such as the Analytical Target Profile (ATP) and Analytical Control Strategy (ACS) will be explained with examples. Test methods often lack robustness because of poor documentation, which can lead to errors or high variability during routine use or method transfer. A risk-based approach to method documentation is included in the course. Each day will conclude with a workshop that will give participants the opportunity to put into practice what they have learned.

    Learning Objectives

    • Update on current regulatory expectations
    • How to write an effective ATP
    • How to set meaningful system suitability criteria as part of the overall ACS
    • Writing method validation, verification and transfer protocols and setting appropriate acceptance criteria
    • Allowable changes to compendial chromatographic methods
    • Parameter-specific validation acceptance criteria and system suitability limits (e.g., elemental impurities and residual solvents)
    • How to avoid common errors in test method documentation
    • Dealing with method validation failure

    Key Topics

    • Life cycle management of analytical methods
      • USP <1220> – Analytical Procedure Life Cycle
      • ICH Q14 – Analytical Procedure Development
      • ICH Q2 (R2) – Validation of Analytical Procedures
      • Options for test method qualification (validation, verification and transfer)
    • US FDA and EMA expectations for test method validation, execution and documentation
    • Compendial guidance on allowable changes to chromatographic methods
    • Deriving method validation acceptance criteria from the ATP
    • Important elements of the ACS
    • A risk-based approach to test method documentation
    • Designing suitable method validation, verification and transfer experiments

    Who should attend?

    Analytical Development Scientists, Quality Control Personnel, Quality Assurance Professionals, Regulatory Affairs Specialists, Project Managers, Consultants

    Our online training experience includes

    • Our client zone – a single source for all training materials as well as pre and post-training communication
    • Live interactive format via the Zoom platform
    • Direct interaction with the trainer
    • Q&As, case studies, polls
    • Revisit recorded sessions for 7 days
    • Training in digital format
    • Digital and LinkedIn certificates


    Dr Mark Powell
    Dr Mark Powell a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a senior analytical chemist. Mark has served as both Honorary Secretary and Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016.
    1 850  Price incl. VAT: 1 850 
    Equivalent of approx. 2 073 USD.
    The price calculation in USD is informative and might slightly differ from your bank exchange rate

    Price per delegate including:

    Online participation

    Recorded sessions for 7 days

    Online workbook & materials


    PC, microphone, camera, stable internet connection and the Zoom application.

    Yes, we will make every effort to ensure best possible interaction. You will see the slides, interact with the trainer and fellow participants. Questions and group exercises will be facilitated through the online meeting platform.

    Yes, you can transfer the registration to a colleague at any time.

    Yes, you may transfer your registration to a different event up to one month before the scheduled dates, provided the training fee has been paid in full.

    pharma learning leader

    Lydia Makori
    +421 222 200 543

    Training Details
    • Start Date
      3. June 2024
      09:00 AM Vienna time
      08:00 AM London time
      03:00 AM New York time
      12:00 AM Los Angeles time
    • End Date
      5. June 2024
    What participants said about this course

    "Dr Mark Powell is very engaging and available. The whole training was well organised."
    Analytical Development Implementation Manager, Novartis

    "The good interaction with the audience helped solidify the experience."
    Laboratory Expert, Ibioc

    "I enjoyed the whole training, especially the ICH14 part."
    Method Development & Validation Coordinator, Sanofi

    "Enjoyed Mark's professionalism and availability. All questions were answered."
    R&D Technician, Novo Nordisk

    "Really enjoyed Mark's clear explanations and way of talking. Very educational. Thank you."
    Research Scientist, Pharos