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 and chapters for integrated validation, verification and transfer of analytical procedures, for equivalency testing and for statistical evaluation.
The 3 hour web seminar will give attendees the background to understand the requirements and even more importantly it will focus on strategies and provide tools to implement most critical requirements. It also provides 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 life examples.
Areas Covered in the Webinar:
Part 1: Regulatory background and requirements
FDA and international requirements
The importance of ICH Q2 and USP chapters
USP approach for method validation: USP Chapters 1220, 1224, 1225, 1226
Learnings from the NEW FDA and WHO method validation guidelines
Different method validation requirements for GLP, GCP and GMP
The importance and steps of risk assessment for testing validation parameters
Exercise: Define risk numbers for different methods
Method revalidation and ongoing performance review
Lessons from recent FDA inspections and Warning Letters
Lifecycle approach and Quality by Design (QbD) for method development and validation
Part 2: Validation of analytical methods and procedures
Developing a validation plan and SOP
ICH Q2 and USP 1225 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
Handling deviations from expected test results
Going through an example validation report
Part 3: Verification of compendial and transfer of analytical 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
The main objective of formal method transfer
Learnings from EU GMP Chapter 6 or method transfer
USP < 1224> : Choosing the approach for transfer
Approach and benefits of comparative testing:
Developing a risk based test plan
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 and chapters for integrated validation, verification and transfer of analytical procedures, for equivalency testing and for statistical evaluation.
The 3 hour web seminar will give attendees the background to understand the requirements and even more importantly it will focus on strategies and provide tools to implement most critical requirements. It also provides 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 life examples.
Areas Covered in the Webinar:
Part 1: Regulatory background and requirements
FDA and international requirements
The importance of ICH Q2 and USP chapters
USP approach for method validation: USP Chapters 1220, 1224, 1225, 1226
Learnings from the NEW FDA and WHO method validation guidelines
Different method validation requirements for GLP, GCP and GMP
The importance and steps of risk assessment for testing validation parameters
Exercise: Define risk numbers for different methods
Method revalidation and ongoing performance review
Lessons from recent FDA inspections and Warning Letters
Lifecycle approach and Quality by Design (QbD) for method development and validation
Part 2: Validation of analytical methods and procedures
Developing a validation plan and SOP
ICH Q2 and USP 1225 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
Handling deviations from expected test results
Going through an example validation report
Part 3: Verification of compendial and transfer of analytical 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
The main objective of formal method transfer
Learnings from EU GMP Chapter 6 or method transfer
USP < 1224> : Choosing the approach for transfer
Approach and benefits of comparative testing:
Developing a risk based test plan
Agenda
Part 1: Regulatory background and requirements
Part 2: Validation of analytical methods and procedures
Part 3: Verification of compendial and transfer of analytical methods
