Master Analytical Method Validation (AMV) with practical training to ensure accuracy, precision & regulatory compliance.
What you will learn
Get Instant Notification of New Courses on our Telegram channel.
Noteβ Make sure your ππππ¦π² cart has only this course you're going to enroll it now, Remove all other courses from the ππππ¦π² cart before Enrolling!
Fundamentals of Analytical Method Validation β Understand the importance, objectives, and regulatory requirements for method validation as per FDA, ICH and USP.
Step-by-Step Validation Process β Learn a structured approach to validating analytical methods, from protocol development to final approval.
Key Validation Parameters & Acceptance Criteria β Master essential parameters, including: Accuracy, Precision, Specificity, Linearity, Range and Robustness.
Method Development vs. Method Validation β Differentiate between method development, validation, verification, and transfer, and know when each is required.
Handling Out-of-Specification (OOS) & Out-of-Trend (OOT) Results β Learn effective troubleshooting techniques to handle unexpected deviations in validation.
Documentation & Compliance Best Practices β Develop skills to create validation protocols, reports, and risk assessments in line with regulatory expectations.
Post-Validation Monitoring & Lifecycle Management β 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.
English
language