Step By Step Guide to Analytical Method Validation
Master Analytical Method Validation (AMV) with practical training to ensure accuracy, precision & regulatory compliance.
4.69 (42 reviews)
1 302
students
1.5 hours
content
Mar 2025
last update
$44.99
regular price
What you will 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.
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6425895
udemy ID
27/01/2025
course created date
27/04/2025
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