Analytical Method Validation Training | Course

Description

Mastering Analytical Method Validation Training |  Course

Become an expert in Analytical Method Validation with this comprehensive, industry-oriented training program designed as per ICH Q2 (R1/R2) guidelines. This course equips you with the knowledge and practical skills required to develop, validate, and document analytical methods used in pharmaceutical quality control and R&D laboratories.

Learn how to design regulatory-compliant validation protocols, execute studies with confidence, and generate accurate, audit-ready reports for global submissions.

Course Overview

Day 1, Session1
Analytical Method Validation, definition, Principle, chromatographic method classification, guidelines, Analytical Method Validation Parameters (definition & acceptance criteria)

Day2, Session 2
7-Step Analytical Method Validation Strategy, Necessary requirements to start Analytical Method Validation, How to define protocol for assay, related substances test, & content test with case study?

Day3, Session 3
How to perform Specificity, Detection limit (DL) & Quantitation limit (QL)? Case studies

Day 4, Session 4
How to perform Precision (System repeatability, Method repeatability, Intermediate precision & Method reproducibility)? Case studies

Day 5, Session 5

How to perform Precision Accuracy, Recovery, Linearity, Range & Relative response factor (RRF)? Case Study

Day 6, Session 6

How to perform Robustness & Stability of solutions? Case studies

Bonus Features

• Troubleshooting guides and common validation mistakes
• Regulatory insights and compliance tips
• Documentation templates and checklists
• Interview questions and expert recommendations

Who Should Attend?

• Analytical chemists and AR&D professionals
• QA/QC analysts and laboratory personnel
• Pharma R&D and quality professionals
• Students and freshers aiming for pharma careers

Why Choose This Course?

• Aligned with ICH Q2 and global regulatory expectations
• Practical, job-oriented training approach
• Real-time examples and industry case studies
• Enhances career opportunities in QC, QA, and R&D

Master the science of analytical method validation and build confidence to meet regulatory requirements, ensure data accuracy, and excel in pharmaceutical quality and compliance roles.

Sessions: 6 sessions (9 hours / 540 minutes each)

Mode of Training: Online (via Google Meet)

Certificate: Yes, a certificate of completion will be provided

Money-Back Guarantee: 30-day money-back guarantee

Outcome:

• Strong foundational knowledge
• Clear career direction
• Improved decision-making for advanced learning

Language: English

Instructor: Dr Pramod Kumar Pandey (PhD in Chemistry) | 31+ years of experience in global and Indian pharmaceutical industries