Step By Step Guide to Analytical Method Validation
What you'll learn
- Fundamentals of Analytical Method Validation – Understand the importance, objectives, and regulatory requirements for method validation as per FDA, ICH and USP.
- Step-by-Step Validation Process – Learn a structured approach to validating analytical methods, from protocol development to final approval.
- Key Validation Parameters & Acceptance Criteria – Master essential parameters, including: Accuracy, Precision, Specificity, Linearity, Range and Robustness.
- Method Development vs. Method Validation – Differentiate between method development, validation, verification, and transfer, and know when each is required.
- Handling Out-of-Specification (OOS) & Out-of-Trend (OOT) Results – Learn effective troubleshooting techniques to handle unexpected deviations in validation.
- Documentation & Compliance Best Practices – Develop skills to create validation protocols, reports, and risk assessments in line with regulatory expectations.
- Post-Validation Monitoring & Lifecycle Management – Understand ongoing method performance monitoring and continuous improvement strategies.
- By the end of this course, you will have the expertise to conduct analytical method validation with confidence, ensuring compliance, accuracy, and efficiency.
Requirements
- No prior validation experience is required! This course covers everything from basics to advanced techniques, making it ideal for both beginners and experienced professionals.
Description
The Analytical Method Validation Course - AMV is a comprehensive training program designed for pharmaceutical professionals who want to master the critical process of validating analytical methods. This course is essential for quality control analysts, R&D scientists, regulatory personnel, and anyone involved in ensuring the accuracy and reliability of analytical data in pharmaceutical laboratories.
The course covers all aspects of analytical method validation as per global regulatory guidelines like ICH Q2(R1). It provides step-by-step training on parameters such as accuracy, precision, specificity, linearity, robustness, limit of detection (LOD), and limit of quantitation (LOQ). Participants will learn how to design and execute validation protocols, analyze results, and prepare detailed validation reports that meet international standards.
What sets this course apart is its practical, hands-on approach. Real-world examples and case studies ensure that learners can directly apply their knowledge to their work. Additionally, the course includes tips and best practices to overcome common challenges encountered during validation, making it ideal for both beginners and experienced professionals. The course applies to both High Performance Liquid Chromatography - HPLC and Gas Chromatography - GC.
By the end of the course, participants will be equipped with the skills and confidence to validate analytical methods effectively, ensuring compliance with regulatory requirements and maintaining product quality. The training also emphasizes the importance of data integrity and reproducibility, which are critical for passing audits and inspections.
Key Highlights:
Comprehensive coverage of all validation parameters.
Hands-on learning with real-world examples.
Practical guidance on preparing validation protocols and reports.
Aligned with international regulatory guidelines.
Take your pharmaceutical career to the next level! Enroll today to become an expert in analytical method validation and contribute to the development of safe and effective medicines.
Who this course is for:
- Pharmaceutical & Biotech Industry Professionals – QC/QA analysts, regulatory affairs professionals, and those involved in method validation, verification, and transfer.
- Laboratory Analysts & Scientists – Those working in R&D, quality control (QC), and quality assurance (QA) who need to validate analytical methods as per ICH, USP, and FDA guidelines.
- Regulatory & Compliance Specialists – Professionals ensuring laboratory methods meet global regulatory requirements and withstand audits.
- Academics & Research Scholars – Students and researchers in pharmaceutical sciences, chemistry, and biotechnology looking to expand their expertise in method validation.
- Manufacturing & Production Personnel – Professionals involved in process validation, formulation, and product development who need an understanding of analytical method validation.
Instructor
- 4.4 Instructor Rating
- 209 Reviews
- 2,651 Students
- 4 Courses
Ankur Choudhary is a recognized Good Manufacturing Practice (GMP) expert known for his valuable contributions to the pharmaceutical and healthcare industries.
Ankur Choudhary possesses extensive knowledge and expertise in Good Manufacturing Practice (GMP), GLP, Regulatory Compliance, and Validation. He is well-versed in the regulations, guidelines, and best practices that ensure the safety and quality of products in the pharmaceutical and healthcare industries.