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Who should attend Seminar on Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)
QA Managers and Personnel, Quality Control, Method Development, Analytical Chemists, Validation Specialists, Laboratory Managers and Supervisors, Regulatory Affairs, Training Departments, Documentation Departments, Consultants
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Seminar on Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)  

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Seminar Summary:

This 2-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. (see full course description)

 
 

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Training Course Syllabus:


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

Overview: 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 2-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.

Agenda:

Day 1 Schedule

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 2 Schedule

Lectures and Workshop Exercises

Lecture 1:
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:: 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 "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

Speaker:

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

Author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems"
 

Seminar Summary:

This 2-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. (see full course description)

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