Analytical Methods Validation - ICH Q14 Overview for Regulatory Approval

Ensuring the accuracy, reliability, and compliance of analytical methods is a critical requirement in pharmaceutical and biotech industries. The ICH Q14 guideline introduces a systematic approach to analytical procedure development and its validation, helping organizations meet regulatory expectations and improve product quality.

This expert-led webinar will provide a comprehensive breakdown of analytical method validation, covering key principles, regulatory requirements, and practical strategies to ensure compliance with FDA, USP, and ICH guidelines. Whether you are involved in method development, validation, or regulatory affairs, this session will equip you with the latest best practices and risk-based approaches essential for achieving successful regulatory submissions and approvals.

WHY YOU SHOULD ATTEND:

Regulatory agencies like the FDA and EMA expect analytical methods to be scientifically sound, validated, and aligned with global quality standards. However, failing to meet these requirements can lead to FDA 483 observations, product recalls, and costly delays.

This webinar will help you:

• Understand the ICH Q14 guideline and its impact on analytical procedure validation.
• Learn how to design and validate robust analytical methods to support regulatory filings.
• Avoid common compliance pitfalls that lead to regulatory rejections.
• Enhance the accuracy, precision, and robustness of your methods using risk-based approaches.
• Gain insights into phase-appropriate validation strategies for clinical and commercial applications.

AREAS COVERED:

• Introduction to Analytical Method Validation: Importance, regulatory expectations, and key definitions.
• Regulatory Landscape & ICH Q14: Understanding FDA, ICH, and USP guidelines (ICH Q14, Q2(R2), 21 CFR Part 211, USP <1225>).
• Critical Validation Parameters: Accuracy, precision, specificity, linearity, detection limits, robustness, and system suitability.
• Risk-Based Method Development: How to apply a risk-management approach in analytical validation.
• Phase-Appropriate Validation: Strategies for different phases of drug development (Phase I, II, III, and commercial).
• Forced Degradation & Stability-Indicating Methods: Ensuring method suitability for stability studies.
• Lifecycle Management of Analytical Procedures: Maintaining compliance post-validation.
• Common FDA 483 Findings & Best Practices: Avoiding regulatory red flags and audit failures.
• Method Verification & Transfer: Ensuring method reproducibility across laboratories and sites.

WHO SHOULD ATTEND:

• Quality Assurance Departments
• Quality Control Departments
• Research and Development Departments
• Analytical Development Professionals
• Regulatory Affairs Departments
• Compliance Departments
• Manufacturing Departments
• CMC & Process Development Professionals
• Method Validation & Laboratory Operations Professionals
• Clinical & Preclinical Research Teams
• GMP & GLP Auditors

Course Director: SCOTT R. THATCHER

Scott Thatcher is a 20+ year veteran of the pharma/biopharma industry. He is a published author in analytical chemistry and photostability studies.  He has contributed to the CMC development and launch of multiple drug programs in different delivery systems. He has executed stress studies for the development and validation of 100s of analytical methods. He is an expert in the interpretation of the ICH Q1B guideline and has contributed to multiple regulatory submissions that met regulatory requirements and subsequent agency approval.