Count Every Second Until the Event

2023-05-11 8:30

Course Overview

Stability evaluation occurs at various stages during the development of a drug product. At early development stages, it is used to select formulations and packaging configurations that are most likely to give a commercially viable shelf life. At later stages, stability data from formal studies is used to justify product shelf life (in the primary pack), shipping excursions and process hold times. This course covers the science behind stability evaluation as well as regulatory expectations.

Risk-Based Stability Evaluation of Pharmaceuticals Masterclass is a live, two-days course, which begins with an overview of the types of stability study conducted (including predictive stability studies), followed by a review of current regulatory expectations. It is important that forced degradation studies are predictive of real-time and accelerated conditions, and an approach that makes this more likely is described, including the use of a humidity-corrected Arrhenius model (Accelerated Stability Assessment Programme, or ASAP).

Within the ICH regions (Climatic Zones I and II), the Q1 stability guidelines are followed, but for companies seeking global approval for new drug products, the requirements for other regions are described. The science behind photostability evaluation is explained, together with the requirements for data trending and reduced study designs (bracketing and matrixing). The stability of biological products (ICH Q5C) is described, together with typical protein degradation pathways and analytical approaches.

Recently, the IQ Consortium has published a series of papers proposing updates to current stability guidance. They have recommended a risk-based life cycle management approach to stability evaluation for chemical drugs and biologics in line with the principles of Quality by Design (ICH Q8), quality risk management (ICH Q9) and drug product life cycle management (ICH Q12). The IQ Consortium approach focuses on understanding the risks to drug product stability and designing a formulation (including material attributes), manufacturing process and primary pack that together mitigate those risks.

Learning Objectives

  • A deeper insight into the science behind stability evaluation
  • An appreciation of the use of stability evaluation at each stage of drug development
  • An understanding of how to design efficient stability studies that meet the requirements of regulatory authorities
  • An understanding of how to design stability studies in line with the principles of Quality by Design
  • An insight into designing a risk-based stability study
  • Answers to your questions on stability studies

Why join the event

Key takeaways of the program

You want to understand how to design effective and efficient stability studies

You would like to know more about the science behind stability evaluation

You would like to understand how to design stability studies in line with the principles of Quality by Design

You want to understand the key inputs to stability prediction tools

You want an overview of regulatory requirements relating to stability studies

You would like to get a deeper insight into risk-based stability evaluation

You would like to improve the predictive nature of stress studies

You would like to improve data quality and your approach to result trending

Who Should Attend

An event precisely for you

Stability Managers / Staff
Stability Managers / Staff
QA/QC Professionals
QA/QC Professionals
Formulation Development Scientists
Formulation Development Scientists
Analytical Development Scientists
Analytical Development Scientists
Regulatory Affairs Personnel
Regulatory Affairs Personnel
CMO / CRO Scientists
CMO / CRO Scientists

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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