Validation and Verification of Analytical Methods – in Pharma & Medical Devices – Coming Soon

Validation and Verification of Analytical Methods Professional Training

Master the critical regulatory requirements and technical expertise essential for analytical method validation in pharmaceutical manufacturing.

This comprehensive one-day seminar provides regulatory professionals with practical knowledge of ICH Q2/Q7 guidelines, Pharmacopoeial Chapters <1224>, <1225> and <1226>, and validation parameters across all test categories.

Through practical examples and real-life case studies, participants will learn about analytical method characteristics, acceptance criteria, protocol and report writing, and regulatory expectations.

Course Details

Duration: 1 day
Date: New date coming soon
Previous cycle ended: 20.05.2026
Hours: 09:30–15:30
Format: Online

What You Will Learn

• Regulatory requirements: ICH Q2/Q7 and Pharmacopoeial Chapters <1224>, <1225> and <1226>
• Structure of analytical procedures and chromatography basics
• System Suitability Test acceptance criteria
• Specificity
• Linearity and range
• Accuracy and precision
• LOD and LOQ
• Robustness
• Solution stability
• Protocol and report writing for validation and verification
• Practical examples and case studies

Who Should Attend?

• Analytical laboratory staff and R&D personnel
• QA staff and laboratory managers
• Professionals in pharmaceutical companies and medical device manufacturers that apply analytical methods in testing
• Organizations with laboratories operating under GMP-like conditions, including pharmaceutical-style laboratory environments within medical device companies

Prerequisites

Laboratory staff should have at least one year of experience.