Analytical Method Development and Validation
6 – 8 October 2025
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 the evolving expectations for method validation
Learn how to apply ICH Q2(R2), Q14, and USP <1220> guidelines to support method suitability throughout its lifecycle, aligned with regulatory and compendial requirements.
Avoid errors with risk-based method documentation
Explore a structured approach to writing validation and transfer protocols, reducing variability and documentation mistakes that can cause compliance issues.
Design robust, lifecycle-driven validation studies
Use ATPs and Analytical Control Strategies (ACS) to set meaningful acceptance criteria, build in robustness, and support reliable method transfer across sites.
Align method strategy with regulatory success
Ensure methods meet FDA and EMA expectations, support post-approval changes, and help avoid revalidation, transfer delays, or regulatory rejections.
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 full analytical method lifecycle
Learn how to apply the principles of QbD, ATP, and ACS from development through validation, transfer, and routine use.
Apply ICH Q14 and Q2(R2) in practice
Gain hands-on insight into the updated guidances and how to design protocols, define acceptance criteria, and document outcomes effectively.
Design robust, regulatory-aligned validation studies
Link acceptance criteria to method purpose, reduce variability, and demonstrate stability-indicating capability and robustness.
Avoid documentation pitfalls and compliance risks
Identify common errors in test method documentation and understand how to use risk-based approaches to support knowledge management.
Strengthen method transfer and lifecycle maintenance
Ensure successful method transfers across sites and implement sound change control strategies that support ongoing regulatory expectations.
WHO IS THIS TRAINING FOR?
Analytical Development Scientists
Quality Control Personnel
Quality Assurance Professionals
Regulatory Affairs Specialists
Project Managers
Method Validation Scientist
Stability/Impurity Testing Scientist
CMC Scientist
KEY TOPICS
Implement ICH Q14, Q2(R2), and USP <1220> across the method lifecycle
Develop robust analytical procedures using ATP and ACS principles
Design and document validation, verification, and transfer studies
Apply risk-based strategies to method documentation and change control
Ensure regulatory alignment and inspection readiness throughout development
TRAINER
PAST PARTICIPANTS
