#Japan #Tokyo #ICH Q14 #ICH Q2 #Pharmaceutical Validation

Seminar Overview

Title: Introduction to Practical Analytical Method Validation
Date: October 2, 2026 (Friday) 10:00 AM - 4:00 PM
Location: Japan I.R. Headquarters Seminar Room (Akihabara, Tokyo)
Capacity: 16 Participants
Fee: ¥49,500 (including tax) per person (discount available for multiple attendees)
Instructor: Wataru Kokubo (Representative, Farn Consulting Office)

This seminar provides a systematic understanding of the role of analytical methods in pharmaceutical development and the fundamental concepts behind validation. Participants will explore the connection between GMP and quality systems, alongside discussions on lifecycle management based on ICH Q14 and Q2. Topics will include statistical analysis, experimental design, key parameter considerations, and practical points regarding active ingredients, formulations, and liquid chromatography.

Seminar Content

1. Fundamentals of Analytical Methods (Concepts and roles in pharmaceutical development)
2. Validation and GMP (Basic concepts and related guidelines, relationship with GMP)
3. Validation in Quality Systems (Quality risk management, lifecycle management, ICH Q14 and Q2)
4. Preparation and Planning for Validation (Statistical analysis, experimental design, management of measuring instruments and computer systems)
5. Validation Parameters (Accuracy, precision, specificity/selectivity, reporting range, calibration curves, detection and quantitation limits)
6. Validation of Analytical Methods for Active Ingredients and Formulations (Ensuring specificity, confirming accuracy, detailed management of precision)
7. Validation via Liquid Chromatography (Basic knowledge, management of HPLC systems, practical points for implementation)
8. Data Evaluation and Continuous Improvement (Assessment and confirmation, re-validation of analytical performance, sustaining quality over time)

Target Audience

• - Beginners in analytical method validation
• - Individuals involved in the research and development of drugs, as well as those handling active ingredient and formulation analysis
• - Professionals working in quality control, quality assurance, production technology, and regulatory affairs
• - Anyone looking to organize their understanding of ICH Q14 and Q2 from the ground up

This seminar is a part of the ongoing commitment of the I.R. Technical Education Institute, delivering knowledge and expertise necessary for practical application in manufacturing industries.

About Japan I.R. Co., Ltd.

With over 50 years of experience, Japan I.R. offers patent and intellectual property solutions, technical information analysis, and comprehensive educational programs for engineers. We focus on providing specialized practical services driven by technology.

Company Website: Japan I.R.
Technical Education Institute Website: Engineer Education
Address: 3rd Floor, CYK Kanda Iwamoto-cho, 15-1 Kanda Iwamoto-cho, Chiyoda Ward, Tokyo, 101-0033
Telephone: 03-6206-4966