December 13, 2017

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Validation, Verification and Transfer of Analytical Methods Seminar Materials: Understanding and Implementing Guidelines from FDA/EMA, USP and ICH

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Seminar materials from Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)

Analytical methods and procedures should be validated to ensure reliability, consistency and accuracy of analytical data. Compendial methods should be verified to demonstrate the suitability of laboratories to successfully run the method and when methods are transferred between laboratories successful transfer should be demonstrated through testing. In case a laboratory wants to use an alternative method instead of a compendial method, equivalency of the alternative method to the compendial method should be demonstrated.

Method validation recently got highest attention from regulatory agencies and industry task forces. For example, FDA and EMA released guidelines on method validation and transfer, and USP has proposed new approaches chapters for integrated validation, verification and transfer of analytical procedures, for equivalency testing and for statistical evaluation.

Lectures and Workshop Exercises

Lecture 1 : Regulatory Background and Requirements

FDA and international requirements
The importance of ICH Q2 and USP chapters
USP approach for method validation: New/revised Chapters 220, 1200, 1210, 1220, 1225
Learnings from the NEW FDA and WHO method validation guidelines
Different requirements for GLP, GCP and GMP
The importance and steps of risk assessment
Exercise: Define risk numbers for different methods
Lessons from recent FDA Warning Letters
Planning for cost-effective implementation

Lecture 2 : Preparing Your Lab for Validation Studies

Analytical Instrument qualification
Part 11/Annex 11 compliance of computer systems
Validation of chromatographic data systems
Validation and control of Excel spreadsheets
Qualification of reference standards and materials

Lecture 3 : Validation of Analytical Methods and Procedures

Developing a validation plan and SOP
ICH Q2 validation and test parameters:
Accuracy, precision, intermediate precision, specificity, LOD, LOQ, linearity, range, robustness, ruggedness
Examples for application specific acceptance criteria
Examples for design and execution of test experiments
Evaluation of test results: using statistical models
Handling deviations from expected test results
Going through an example validation report

Lecture 4 : Verification of Compendial Methods

FDA and equivalent international expectations
Scope and objectives of USP
USP verification requirements
Risk based approach for type and extent of verification testing
Which validation parameters should be verified
Logical process to set acceptance criteria
Exercise: Application based verification testing

Day 02 (8:30 AM – 4:30 PM)Day 2 – Lectures and Workshop ExercisesLecture 5 : Transfer of Analytical Methods and Procedures

The main objective of formal method transfer
Learnings from EU GMP Chapter 6 on method transfer
USP : Choosing the approach for transfer
Approach and benefits of comparative testing:
Developing a risk based test plan
Planning and developing an effective transfer protocol
Preparing the receiving lab for the transfer
Method transfer to new technology::

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