Count Every Second Until the Event

2023-10-03 14:30

Course Overview

As early as 2018, the ICH announced that the Q2(R2)/Q14 Expert Working Group (EWG) would develop a new ICH quality guideline, ICH Q14, for the development of analytical methods and revise the ICH Q2(R1) guideline for the validation of analytical procedures. This will complement the existing ICH Q8 to Q12 guidance and the current ICH Q13 guidance for continuous manufacturing. The new Analytical Procedure Development Guideline (Q14) will then be relevant for sections S4, P4 and P5 of the CTD and should be seen together with Q8(R2) and Q11 as a supplement to the guidelines. The use of the enhanced approach to analytical procedures development and validation can contribute to resource-efficient drug development as well as submission process or facilitate changes after CMC approval. The revised Q2(R1) guideline will also be relevant for sections S4, P4 and P5 of the CTD, with an emphasis on systematic analytical development. As development and validation are linked and subsequent steps, both guidelines will be worked on by the same Expert Working Group, with a potential to combine both documents into one.

The purpose of the 2-day course, Analytical Method Validation & Lifecycle Management Masterclass, is to explain these new guidance in the context of other compendial and regulatory agency expectations and to help attendees avoid common mistakes during the development, validation, verification, transfer and post-approval change 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.

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 expectations for test method validation, execution and documentation
  • EU and US compendial guidance on 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

Why join the event

Key takeaways of the program

Learn how to write an effective ATP

Learn how to set meaningful system suitability criteria as part of the overall ACS

Dive deep into writing method validation, verification and transfer protocols and setting appropriate acceptance criteria

Understand allowable changes to compendial chromatographic methods

Understand how you can avoid common errors in test method documentation and follow a risk-based approach

Learn how to deal with method validation failure

Design suitable method validation, verification and transfer experiments

Get yourself updated on current regulatory expectations including FDA guidance

Who Should Attend

An event precisely for you

Analytical Scientists
Analytical Scientists
Regulatory Affairs Personnel
Regulatory Affairs Personnel
QA/QC Professionals
QA/QC Professionals
Development Scientists
Development Scientists
CMO / CRO Scientists
CMO / CRO Scientists
Consultants & Project Managers
Consultants & Project Managers

The speaker

Meet your trainer

Dr Mark Powell is 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 AnalyticalDivision and led a working group on continuing professional development until July 2016.

He has worked at a senior level in several companies with responsibility for analytical development and equipment qualification. In 2010 Mark was appointed Scientific Manager of a UK-based pharmaceutical CRO, with responsibility for guiding the direction of drug development programmes, including stability evaluation.

In 2013, he set up his own company to provide training and consultancy services to the pharmaceutical industry. His consultancy work has involved managing the analytical and stability aspects of early and late-stage pharmaceutical development programmes and conducting data integrity audits. He is in demand as a trainer in topics such as pharmaceutical development, chromatography, spectroscopy, dissolution testing, data integrity, control of impurities, technical writing, root cause analysis and stability/stress studies.

Dr. Mark Powell

Dr. Mark Powell

Mark Powell Scientific Limited

The Curriculum

What you’ll get from this exclusive event

Fresh Content

Knowledge is only useful when it is relevant. This event is based on the latest research, best practices and industry information. As a result, we close events with a strong knowledge base that helps achieve same-day results.


Meet and collaborate with like-minded professionals across the globe. Grow your professional network, exchange ideas, and learn more about the industry with your own peers, together.


Experience comes with practice, and this event will guide you on the right path in becoming a well renowned expert in your field. You will learn through a combination of lecture-based content, real-life case studies, and a more hands-on experience.

Q&A Session

By joining this class, you will be given the opportunity to constantly engage with your peers and raise your concerns, questions, or doubts you may have pertaining to the subject. And, receive well-founded, well-thought-out answers to your every need by leading experts in the industry. 

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