Practical Implementation of ICH Q2(R2) and USP Requirements
Analytical method validation is more than executing experiments and filling in templates. It requires a clear understanding of performance characteristics, risk-based thinking, and regulatory expectations.
We offer a practical, on-request training course delivered on site at your organization, tailored to your analytical methods, products, and development stage.
This course provides a structured and practical translation of:
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ICH Q2(R2) – Validation of Analytical Procedures
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Relevant USP chapters (including general validation principles and technology-specific guidance)
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Lifecycle alignment with ICH Q14 where applicable
Rather than focusing solely on theory, this training emphasizes how to design validation studies that are scientifically sound, efficient, and inspection-ready.
What the training covers
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Validation strategy and performance characteristics
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Accuracy, precision, specificity, linearity, range, and robustness
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Combined accuracy and precision concepts
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Total error thinking
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Use of development data in validation
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Setting appropriate acceptance criteria
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Technology-inherent justification and orthogonal approaches
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Practical pitfalls and inspection findings
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Alignment between validation, lifecycle management, and control strategy
The course is interactive and highly practical. Real-life examples are used throughout, and participants are encouraged to discuss their own validation challenges.
Why this training?
Many organizations still apply a checklist-based validation approach.
ICH Q2(R2) and USP expectations require a more scientific and risk-based mindset.
This course helps your team move from compliance-driven validation to scientifically justified validation — improving robustness, efficiency, and regulatory confidence.