Extractables and Leachables

    Extractables and Leachables Control Strategies

    Dates 2024 TBC, live online training


    Regulatory expectations for the control of extractables and leachables (E&L) have evolved greatly in recent years. This three-day course sets out the regulatory and scientific considerations concerning E&L in a logical, stepwise manner and offers practical advice for compliance. The course answers questions such as: “When is an extractable/leachable study necessary?”, and “How do I choose appropriate extraction conditions?”. Regulators will expect a risk-based approach to compliance, and the steps involved in an E&L risk assessment are described. The course draws on information contained in current regulatory guidance (such as ICH Q3E) as well as influential publications from bodies such as the Product Quality Research Institute (PQRI), BioPhorum and the Extractables & Leachables Safety Information Exchange (ELSIE).

    Learning Objectives

    By attending this course, you will:

    • Understand how extractables and leachables fit into the wider context of pharmaceutical impurities
    • Be able to identify the common types of leachable contaminants associated with different packaging materials
    • Know how to perform an extractables/leachables risk assessment
    • Be aware of current EU, US and WHO guidance on extractables and leachables
    • Appreciate the risks from glass and plastic materials
    • Understand the analytical approaches to extractables and leachables analysis
    • Be aware of common analytical errors that can affect data reliability
    • Become familiar with the Extractables and Leachables Safety Information Exchange (ELSIE) and its approach to controlling leachables risk.

    Key Topics

    • General approaches for the control of pharmaceutical impurities
    • Options for setting control limits (the Safety Concern Threshold)
    • Applying the principles of quality risk management to E&L
    • Common leachables from glass and plastic materials and their impact on product quality
    • Designing an appropriate extractables study
    • Analytical approaches for the detection, identification, and quantitation of E&L
    • Specifying the Analytical Evaluation Threshold (AET)
    • Common analytical errors in E&L studies
    • The ELSIE approach to risk-based E&L control

    Who should attend?

    The course is intended for:

    Personnel of pharmaceutical companies and their suppliers who:

    • are responsible for qualification of extractables/leachables
    • perform leachables/extractables testing
    • work in quality control of packaging materials
    • select packaging and product contact materials

    As well as:

    • Regulatory affairs professionals
    • Product development managers
    • Analytical chemists
    • Quality assurance personnel
    • Toxicologists

    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.

    A Risk-Based Approach to the Control of Extractables and Leachables

    Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

    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
    What participants said about this course

    "Got up to date with regulatory expectations. My main questions were satisfactorily addressed."
    Head of Devices and Delivery Systems Sciences, UCB Pharma

    "Thank you for easy access to content and clear documentation."
    Scientist, RBM Merck Group

    "Mark was really open to questions and did answer them very well."
    Principal Scientist, Byondis

    "Discussion on analytical techniques & analytical errors was very helpful."
    Senior Scientific Expert, Merz Aesthetics

    "The regulatory information was very useful."
    Head of Manufacturing, IDT Biologika

    "I enjoyed the fact that I could do it from home."
    Technical Consultant, Eurofins Biolab

    "Mark was very knowledgeable and really did a great job to provide everybody with a satisfactory answer to their question."
    Project Manager, Bioglan

    "Overall a great course, thank you!"
    Validation Engineer, Merz Pharma

    "Very good speaker, very informative course."
    Manager Medical R&D, Chanelle Pharma