About course section
- Minimal: Traditional one‑time method development and validation.
- Enhanced: Incorporates Analytical Target Profile (ATP), risk analysis, robustness studies, design regions, and method lifecycle management—enabling adaptive and flexible control.
- A profile similar to QTPP, defining the intended measurement performance (specificity, accuracy, precision, range) and guiding method development
- Uses risk tools and DoE to define operational ranges and establish method operable design regions (MODRs) or proven acceptable ranges (PARs)
- Integrates established conditions and system suitability testing (SST) to ensure consistent method performance during routine use
- Provides a risk-based framework for handling method changes post-approval, aligned with ICH Q12 tools—enabling differentiated reporting based on established conditions
- Addresses advanced analytical techniques, including multivariate model development and RTRT considerations
- Outlines CTD documentation expectations, especially under the enhanced approach where development rationale, risk analysis, and lifecycle plans are included
- The difference between minimal (traditional) vs enhanced (QbD) analytical development approaches.
- How to define and use an Analytical Target Profile (ATP) to guide development.Techniques for establishing robustness, operational design regions, and control strategy (SST, MODRs).
- Risk‐based lifecycle management, including change categorization and post‑approval flexibility.
- Approaches to developing multivariate analytical methods and strategies for real‑time release testing.
- Best practices for documenting method development and lifecycle management in CTD submission.

Trainer - Kajal Patel
Kajal Patel holds a Master’s degree in Quality Assurance and began her regulatory career in 2012, working across ROW and EU markets. With over a decade of experience, she has developed strong expertise in CMC document review, dossier compilation, lifecycle management, and regulatory strategy. Her work often involves close coordination with cross-functional teams to ensure timely and compliant submissions.
Since joining ISAZI in 2022 as a Business Development professional, Kajal has combined her technical regulatory knowledge with strategic planning to support client engagement and training initiatives. She has played a key role in guiding pharmaceutical teams through regulatory challenges, drawing from her experience with product registrations and post-approval changes.
In her ICH guideline training sessions, Kajal brings a practical, submission-focused approach. She emphasizes real-world application of regulatory principles, making complex guidelines easier to understand and implement for professionals at all levels.