Past Event

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

9–10 October 2017
Burlingame, CA 94010, United States

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

Mon, Oct 9, 2017, 9:00 AM –
Tue, Oct 10, 2017, 6:00 PM PDT

Hilton San Francisco Airport Bayfront
600 Airport Boulevard
Burlingame, CA 94010
United States

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.

This two-day workshop will give attendees the background to understand the requirements, and even more significantly, it will focus on strategies and provide tools to implement most critical requirements. It will also provide templates and examples to develop inspection ready documentation. Interactive workshop exercises will be dispersed into and between the presentations. About 50% of the total time will be dedicated to practical sessions with real life examples. After the course a variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what attendees have learned in the course.
Learning Objectives:

    Learn about the regulatory background and requirements for validation of analytical methods and procedures
    Learn how to plan, execute and document development and validation of methods developed in-house
    Be able to explain the different requirements for validation, verification and transfer of analytical procedures
    Understand the principles of validating methods developed in-house, verification of compendial methods, transfer of analytical procedures and demonstrating equivalency to compendial methods
    Be able to explain your company's strategy for method validation, verification, transfer and equivalency testing
    Be able to select test parameters, test conditions and acceptance criteria for different analytical tasks
    Be able to justify and document decisions about revalidation after method changes
    Be able to define and demonstrate FDA and EU compliance to auditors and inspectors
    Be able to develop inspection ready documentation during on-going routine operation
    Understand statistical evaluation of validation test results
    Understanding what questions will be asked during audits and inspections and how to answer them

Who will benefit:

    QA Managers and Personnel
    Quality Control
    Method Development
    Analytical Chemists
    Validation Specialists
    Laboratory Managers and Supervisors
    Regulatory Affairs
    Training Departments
    Documentation Departments

Day 1 Schedule
Lectures and Workshop ExercisesLecture 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:

Going through the new FDA Method Validation guidance

    Scope and enforcement of the guidance
    Recommendations for integrated procedure lifecycle
    Expectations for quality risk assessment, Quality by Design (QbD), multivariate experiments, system suitability testing, statistics,
    Revalidation vs. periodic review
    Preparing the lab for GMP compliant validation studies

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 <1226>
    USP <1226> 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 2 Schedule
Lectures and Workshop ExercisesLecture 1:

Transfer of Analytical Methods and Procedures

    The main objective of formal method transfer
    Learnings from EU GMP Chapter 6 on method transfer
    USP <1224> : 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: HPLC to UHPLC
    Preparing the method transfer report
    Exercise: Application specific comparative testing

Lecture 2:

Demonstrating Equivalency to Compendial Methods

    Method validation vs. equivalency testing
    Definition, objective and scope of alternative methods
    Justification for the use of alternative methods
    FDA and USP requirements
    Options for alternatives to approved procedures
    Exercise: Equivalency testing - what and how much
    Documentation requirements

Lecture 3:

Maintaining the Validated State

    Monitoring method performance: system suitability testing and quality control samples
    Change control procedure for analytical methods
    Handling method changes vs. adjustments
    Revalidation of analytical methods: when, what to test
    Method reviews as a cost effective alternative to time based revalidation
    Going through a review process
    Regulatory reporting of post-approval changes
    Examples for continuous improvements

Lecture 4:

Special Applications and Validation Processes

    Preview to the expected new USP general chapter <1220> "The Analytical Procedure Lifecycle"
    Method development and validation using Quality by Design principles following the new FDA Guidance
    Validation of bioanalytical methods according to the FDA and EMA guidelines
    Validation of stability indication method

Dr. Ludwig Huber
Chief Advisor - Global FDA compliance, Labcompliance

    Chairman, presenter and panel discussion member at US-FDA Industry Training sessions and conferences
    Served as team member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP� special interest group on Laboratory Systems.
    Presenter of the Year of the Institute for Validation and Technology
    Director and chief editor of, the global on-line resource for validation and compliance issues for laboratories.
    Author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems"


  • Dr. Ludwig Huber Chief Advisor - Global FDA compliance, LabcomplianceFind out more