3-Hour Virtual Seminar on Validation, Verification and Transfer of Analytical Methods - Implementing Guidelines from FDA-EMA, USP and ICH

The 3-hour virtual seminar will give attendees the background to understand the requirements and even more importantly it will focus on strategies and provide tools to implement even most critical requirements.

Why should you Attend: 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 to 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.

Areas Covered in the Session:

Lecture 1: Regulatory background and method validation according to ICH Q2 and USP 1225
• FDA and international requirements
• The importance of ICH Q2 and USP chapters
• Different requirements for GLP, GCP and GMP
• Impact of pharmaceutical quality systems
• The importance of risk assessment
• Lessons from recent FDA Warning Letters
• Planning for cost-effective implementation
• Developing a validation plan and SOP
• ICH Q2 validation and test parameters: Accuracy, precision, intermediate precision, specificity, LOD, LOQ, linearity, range, robustness, ruggedness
• Setting application specific acceptance criteria
• Efficient design and execution of test experiments
• The integrated method lifecycle management: Activities during development, validation and routine use
• Method development and validation using QbD
• Maintaining the validated state
• Monitoring method performance: system suitability testing and quality control samples

• FDA and equivalent international expectations for verification of compendial methods
• Scope and objectives of USP <1226>
• USP <1226> verification requirements
• Risk based approach for type and extent of testing
• Which validation parameters should be verified
• Demonstrating equivalency to compendial methods
• The main objective of formal method transfer
• Learning from the FDA guide on analytical method transfer
• USP <1224> : Choosing the approach for transfer
• Approach and benefits of comparative testing:
• Developing a risk based test plan: justify and document type and extend of testing
• The importance of the original validation studies
• Responsibilities of the sending and receiving laboratory
• Preparing the receiving lab for the transfer
• The importance of the original validation studies
• Method transfer to new technology: HPLC to UHPLC
• Preparing the method transfer report

• 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

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