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

Training overview
2 days
Classroom / Public

Course description

GlobalCompliancePanel Training Course

Validation, Verification and Transfer of Analytical Methods

It is essential that companies validate their analytical methods and procedures to ensure reliability, consistency and accuracy of this data. In particular, laboratories must verify their compendial methods to demonstrate their ability to successfully run the method and that when methods are transferred between laboratories they test these methods to verify successful transfer. If a laboratory wants to use an alternative method, they need to demonstrate that this method is the equivalent of the compendial method.

Method validation recently received a high level of attention from regulatory agencies and industry task forces. The FDA and EMA have released guidelines for method validation and transfer, and USP has proposed new to integrated validation, verification and transfer of analytical procedures to be used for equivalency testing and statistical evaluation.

This two-day workshop will provide attendees with the background information they need to understand the requirements. It will focus on different strategies and provide tools to help them put these critical requirements in place. They will also be provided with templates and examples of inspection ready documentation. About 50% of the total course time will be dedicated to practical sessions with real life examples. After the course attendees will have access to a variety of tools such as SOPs, validation examples and checklists to help them put their knowledge into practice.

Who should attend?

This seminar is suitable for:

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

Training Content

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

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

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

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


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GlobalCompliancePanel- Quality Training Solutions

GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient. GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such...

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