Validation, Verification and Transfer of Analytical Methods from FDA/EMA, USP and ICH 2017
Course "Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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 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
• Consultants
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:
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 expec
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 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
• Consultants
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:
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 expec
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