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Description:

ICH Q14 provides a science- and risk‑based framework for developing, validating (with Q2 R2), and maintaining analytical procedures for drug substances and products—covering both release and stability testing. It bridges ICH Q8–Q12 principles (especially Q8’s QbD, Q9’s risk management, Q10 and Q12 lifecycle tools), emphasizing the entire analytical procedure lifecycle, including post‑approval change control.

Key Highlights:

1. Minimal vs Enhanced Approaches
  • 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.
2. Analytical Target Profile (ATP)
  • A profile similar to QTPP, defining the intended measurement performance (specificity, accuracy, precision, range) and guiding method development
3. Robustness & Parameter Ranges
  • Uses risk tools and DoE to define operational ranges and establish method operable design regions (MODRs) or proven acceptable ranges (PARs)
4. Analytical Control Strategy
  • Integrates established conditions and system suitability testing (SST) to ensure consistent method performance during routine use
5. Change & Lifecycle Management
  • Provides a risk-based framework for handling method changes post-approval, aligned with ICH Q12 tools—enabling differentiated reporting based on established conditions
6. Multivariate Methods & Real-Time Release Testing (RTRT)
  • Addresses advanced analytical techniques, including multivariate model development and RTRT considerations
7. Regulatory Submission Guidance
  • Outlines CTD documentation expectations, especially under the enhanced approach where development rationale, risk analysis, and lifecycle plans are included
What you will learn:
  • 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.

Course Curriculum

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