Analytical Method Validation

Analytical Method Validation

Validate Methods with Confidence — From Definitions to Execution, Reporting, and Transfer

Analytical Method Validation is essential to demonstrate that analytical procedures are suitable for their intended purpose. It is a mandatory requirement for marketing authorization and a core element of GMP compliance. This training provides participants clear and practical knowledge on how to execute validation parameters, interpret results using appropriate statistical tools, and report findings in accordance with relevant international guidelines and Ministry of Health expectations. The program also explains the differences between validation and verification, and introduces the concept of Method Transfer to ensure smooth operational continuity across laboratories.

Who Should Attend

Research & Development (R&D) personnel
Quality Control (QC) personnel
Registration personnel

Learning Objectives

At the end of this course, participants will be able to:

Execute and report each validation characteristic in accordance with regulatory and Ministry of Health expectations
Apply statistical concepts used in method validation, including calibration curve statistics
Understand the differences between validation and verification of analytical methods
Apply the concept and workflow of Method Transfer to ensure that the receiving QC laboratory can perform the analytical procedure as intended

Course Outline

Over two days, the following topics are covered in detail:

Overview of validation as a general concept
Overview of analytical methods
Validation of analytical procedures — definitions, implementation, criteria, and reporting
Verification of compendial procedures
Transfer of Analytical Procedures (TAP)

Duration

Two days

Key Takeaways

Complete understanding of analytical method validation principles, execution steps, and documentation
Confidence in reporting method validation results aligned with regulatory expectations
Ability to differentiate and apply validation vs. verification of analytical procedures
Practical clarity on the workflow and expectations of analytical method transfer

Categories

We understand the importance of approaching each work integrally and believe in the power of simple.

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