Extractables & Leachables Control
Strategies
2 – 4 March 2026
1 850 €
TRAINING TIMES
13:30 - 18:00 Vienna
12:30 - 17:00 London
07:30 - 12:00 New York
04:30 - 09:00 Los Angeles
WHY SHOULD YOU ATTEND?
Understand E&L in Pharmaceutical Impurities
Learn the role of extractables and leachables (E&L) in drug quality, their sources, and their impact on pharmaceutical impurities, with a focus on ICH Q3E and the new draft guidance.
Design Sound E&L Studies
Get practical guidance on designing E&L studies, including risk-based approaches, extraction conditions, and meeting ICH Q3E and USP requirements.
Apply Risk-Based Approaches to Packaging and Component Selection
Use QRM tools to assess risk and evaluate materials for drug product compatibility, following ICH Q3E principles.
Master Analytical Strategies and Avoid Common Data Pitfalls
Understand key techniques for detection, quantification, and identification of E&L — and how to avoid errors in execution and interpretation.
OUR ONLINE TRAINING EXERIENCE INCLUDE
Three half-days of expert-led Zoom sessions packed with case discussions, Q&As, and real-world scenarios
All slides, tools, and supporting materials available in one place – before, during, and after the course.
Receive a digital certificate (also LinkedIn-ready) that verifies your skills in strategic trial planning.
LEARNING OBJECTIVES
Understand the role of extractables and leachables in pharmaceutical impurities
Gain a solid foundation in how E&L impact product quality and fit into the broader impurity control framework.
Apply regulatory expectations and risk-based thinking
Learn how to interpret and apply global guidance from ICH Q3E, USP <1663>/<1664>, and Ph. Eur., using QRM tools to support compliance.
Design and evaluate extractables and leachables studies effectively
Master the steps to plan, execute, and assess E&L studies—including selecting extraction conditions, applying AETs, and interpreting results.
Mitigate risks from glass and plastic materials
Identify potential leachables from various container types, assess corrosion and additive risks, and select suitable packaging materials.
Improve analytical accuracy and method reliability
Understand the strengths and limitations of key analytical techniques, and avoid common errors that compromise E&L data quality.
WHO IS THIS TRAINING FOR?
Extractables & Leachables Scientists
Analytical Chemists
Quality Control (QC) Scientists
Quality Assurance (QA) Professionals
Regulatory Affairs Specialists
Product Development Managers
Toxicologists
CMC Scientist
KEY TOPICS
Understand regulatory expectations for E&L control
Design and execute effective extractables studies
Assess leachables risk using quality risk management tools
Mitigate risks from glass and plastic materials
Optimize analytical strategies and data integrity
TRAINER
PAST PARTICIPANTS
